President Donald Trump signed an Executive Order in December directing the Attorney General to expedite completion of marijuana rescheduling to facilitate medical research begun in October 2022.  The President opined that federal officials were “slow-walking” marijuana rescheduling during the signing of an Executive Order expanding the review of psychedelic drugs last week.  Then on Thursday, Acting Attorney General Todd Blanche and the Drug Enforcement Administration (“DEA”) issued a final rule rescheduling FDA-approved products containing marijuana and marijuana products regulated by state medical marijuana licenses from schedule I to schedule III of the Controlled Substances Act (“CSA”).  Schedules of Controlled Substances: Rescheduling of Food and Drug Administration Approved Products Containing Marijuana From Schedule I to Schedule III; Corresponding Change to Permit Requirements, 91 Fed. Reg. 22,714 (Apr. 28, 2026).  DEA also under Blanche’s signature issued a notice withdrawing the May 2024 Notice of Proposed Rulemaking for the prior rescheduling hearing and issued a separate Notice of Hearing for an expedited rescheduling hearing to begin June 29^th.  Schedules of Controlled Substances: Rescheduling of Marijuana; Withdrawal,  91 Fed. Reg. 22,778 (Apr. 28, 2026); Schedules of Controlled Substances: Rescheduling of Marijuana, 91 Fed. Reg. 22,777 (Apr. 28, 2026).

Rescheduling became effective immediately.

Setting the Stage

In August 2023, the Department of Health and Human Services (“HHS”) recommended rescheduling marijuana to schedule III after conducting an Eight Factor Analysis under the CSA.  HHS found that 30,000 licensed healthcare practitioners were authorized to recommend marijuana for medical use to over six million patients to treat pain, anorexia related to certain medical conditions, and nausea and vomiting from chemotherapy.  DOJ conducted its own Eight Factor Analysis and concurred with HHS’ recommendation.  Then-Attorney General Merrick Garland signed a Notice of Proposed Rulemaking in May 2024 proposing to reschedule marijuana to schedule III that elicited over 43,500 public comments.  In January 2025, the presiding Administrative Law Judge stayed the DEA public rescheduling hearing pending an interlocutory appeal by several parties.

Final Rule for Approved/Regulated Marijuana Products

Rescheduling and the Treaties:

The final rule limits rescheduling to FDA-approved drug products containing delta-9-tetrahydrocannabinol (“THC”) that meet the CSA’s definition of marijuana derived from the plant Cannabis sativa L., and marijuana products regulated by state-issued licenses to manufacture, distribute, and/or dispense for medical purposes.  The rule notes that forty states have legalized marijuana for medical purposes and have established regimes that incorporate inspections and licensing, recordkeeping and reporting requirements.

The United States, as a signatory to the United Nations Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances, 1971, is required to comply with obligations imposed by those treaties.  Among controls required by the Single Convention for signatories on cannabis, cannabis resin and other Schedule I under the treaty are:

• Limiting the production, manufacture, export, import, distribution of, trade in, use and possession exclusively to medical and scientific purposes;
• Requiring manufacturers and distributors to be licensed;
• Requiring medical prescriptions for dispensing to patients;
• Requiring importers and exporters to be licensed with each import or export requiring a permit;
• Prohibiting possession except under legal authority; and
• Requiring those in the legitimate distribution chain to keep transaction records for two years. Rescheduling of Food and Drug Administration Approved Products at 22,715.

To adhere to the Single Convention’s import/export requirements, the rule amends 21 C.F.R. § 1312.30 to add FDA-approved drug products containing marijuana and state-licensed medical marijuana to the list of nonnarcotic schedule III-V substances requiring import and export permits.

For growing marijuana, the Single Convention requires signatories to:

• Register and regulate growers;
• Limit growing to legitimate domestic scientific, medical, and industrial needs, and for legitimate exports;
• Establish the upper limit of marijuana that each grower may grow in a calendar year and the total amount that can be grown in the U.S. annually for legitimate needs; and
• Purchase all harvested crops of marijuana and monopolize the wholesale trade in harvested marijuana. at 22,716.

To comply with the Single Convention, the rule requires DEA to acquire and resell marijuana crops from registered manufacturers.  Registered manufacturers must store crops in a facility that DEA maintains access to until the transaction is completed.  DEA can require recordkeeping and reporting to comply with the Single Convention and must take into account Single Convention requirements.

The final rule notes that DOJ’s Office of Legal Counsel’s 2024 opinion concluded that if marijuana were rescheduled to schedule III, the U.S. would continue to meet “most” of the obligations imposed by the Single Convention and the Convention on Psychotropic Substances.  The rule also refers to HHS’ August 2023 evaluation and recommendation that DEA reschedule marijuana in schedule III.  Specifically, HHS found that marijuana has a potential for abuse less than drugs and substances in schedule I and II, and that its abuse may lead to moderate or low physical dependence or high psychological dependence.

Title 21 of the U.S. Code, § 811(d)(1) requires the Attorney General to issue an order controlling drugs “under the schedule he deems most appropriate” to carry out treaty obligations.  Id. at 22,715.  The Acting Attorney General states that while he is not required to consider HHS’ rescheduling recommendation “because I believe there are several legally viable scheduling options that would satisfy… obligations under the Single Convention based on OLC’s 2024 opinion… I exercise my discretion in determining the most appropriate schedule by choosing the option that most closely aligns to HHS’s findings and best positions the United States to carry out its obligations under the Single Convention. . . [with respect to] an FDA-approved product or subject to a state medical marijuana license.”  Id. at 22,718.  Blanche ordered FDA-approved drugs products containing marijuana and marijuana in any form covered by a state medical marijuana license rescheduled to schedule III.

All forms of marijuana other than in FDA-approved drug products or marijuana products subject to state medical licenses continue to be regulated as schedule I controlled substances.  The rule does not change the status of bulk marijuana, noting that unlicensed bulk marijuana remaining in schedule I allows the U.S. to meet its obligations under the Single Convention by requiring licensed manufacturers to obtain manufacturing quotas and by DEA buying marijuana crops from registered manufacturers, selling those crops and establishing prices for purchase and sale.  The rule does not impact synthetically-derived THC that is outside of the CSA’s definition of marijuana and not subject to HHS’ scientific and medical evaluation.  It does not impact hemp.  Nor does the rule reschedule any drug product containing marijuana or THC previously rescheduled out of schedule I, which includes Marinol, Syndros and previously scheduled synthetic cannabinoids.

Regulatory Requirements:

Rescheduled FDA-approved drug products containing marijuana and marijuana products subject to a state medical license will require manufacturers, distributors, dispensers and other handlers to comply with federal schedule III regulatory requirements.  Requirements include registering with DEA, taking and maintaining initial and biennial inventories, creating and maintaining transaction records, filing theft and significant loss reports, labeling, and maintaining prescribed security.  Dispensing marijuana to patients requires prescriptions issued for legitimate medical purposes by a DEA-registered and state licensed practitioner.

The rule expressly notes that state licensees will no longer be subject to the Internal Revenue Code’s Section 280E deduction disallowance for businesses engaged in “trafficking in controlled substances… in a schedule I or II.”  Id. at 22,719.

State Regimens:

Noting the robust infrastructure developed by state medical marijuana regulatory systems for preventing diversion, maintaining records and conducting inspections, the final rule found that “incorporating state licensing systems into the federal registration framework represents the most effective and efficient means of achieving the CSA’s objectives with respect to medical marijuana while promoting the medical benefits of marijuana and causing the least disruption for patients and existing state systems.”  Id. at 22,720.  The order mandates an expedited DEA review process whereby state-licensed medical marijuana entities seeking federal manufacturer, distributor and dispenser registrations may submit state credentials as evidence of state law authorization.  The rule requires DEA to issue registrations unless doing so would be inconsistent with the public interest under 21 U.S.C. § 823 or with Single Convention requirements.  The rule directs the agency to process registration applications within 60 days of publication of the rule within six months, and allows early applicants to lawfully operate under their state licenses during the pendency of DEA’s review.

To reduce the regulatory burden on “compliant state-licensed entities,” the rule limits reporting, recordkeeping and order form requirements to those necessary to satisfy federal statutory and treaty obligations, with state-required records accepted to the extent possible.  “State-authorized medical marijuana certifications or similar documents are sufficient to permit the dispensing of medical marijuana to users, provided they include the user’s name and address, are dated and signed on the day of issuance, and identify the issuing practitioner.”  Id.  Further, registrants may comply with state labeling, packaging, disposal, and physical security requirements in lieu of the applicable federal requirements, but subject to inclusion of the statutory warning label required by 21 C.F.R. § 825(c).

The Prior Rescheduling Hearing

DEA determined that the most expeditious manner of completing current rescheduling is to terminate the hearing initiated by the August 29, 2024, notice that began and was stayed in January 2025.  Withdrawal at 22,778.  The agency withdrew the notice of the prior hearing.

A New Hearing

DEA issued a Notice of Hearing on the Proposed Rulemaking for rescheduling marijuana to schedule III to commence June 29 and conclude by July 15th.  Rescheduling of Marijuana at 22,777.  “[T]he purpose of the hearing,” in accord with 21 U.S.C. §§ 811 and 812, “is to ‘receiv[e] factual evidence and expert opinion regarding’ whether marijuana should be transferred to schedule III.”  Id. at 22,778.  Comments or objections to the proposed rule will be offered as evidence at the hearing.  Interested persons are invited to provide written notice of their desire to participate: mailed requests must be postmarked on or before May 20th, electronic requests must be emailed by 11:59 p.m. on May 24th.  The Acting Attorney General will notify those selected to participate in the hearing on June 22nd.

Medical Marijuana Applications

DEA will accept applications for medical marijuana business applications on a dedicated registration portal.  The agency began accepting applications for medical marijuana dispensary registrations on Wednesday.

Last September, we blogged about FDA’s release of Complete Response Letters (“CRLs”) for unapproved NDAs and BLAs, which since then have continued at a steady clip.  We observed that the policy marked a significant change from FDA’s longstanding position that such CRLs were exempt from disclosure under FOIA and FDA’s own regulations, that this shift in policy was accomplished without undertaking expected administrative processes, such as a Federal Register Notice or a docket to solicit public comment, and that litigation may well follow.

We have not seen an industry vs. FDA litigation war break out yet, but along the lines we predicted, a new Citizen Petition (“CP”) is loudly beating the drums.  As just about anyone can submit a CP to FDA on just about anything (see 21 C.F.R. §§ 10.25, 10.30), the mere fact that one has been submitted does not often rise to the level of blogworthiness.  This one is different.  Below we break down this new CP’s request, its extensive supporting rationale, and what might follow it.

The Citizen Petition’s Outward Ask

On April 20, 2026, a major Washington, DC law firm submitted a Citizen Petition to FDA on behalf of “an individual pharmaceutical company,” nominally asking that FDA “establish a clear process that provides applicants with notice and an opportunity to respond to proposed disclosures of CRLs associated with unapproved” NDAs, ANDAs, BLAs, and their supplements and amendments.  Since last September, FDA has decided on its own, without applicant input, what information to redact from a CRL as confidential commercial information/trade secret information (“CCI/TS”) and when to post it on its openFDA website.  The process the CP requests would “mirror” the pre-disclosure notification process (“PDN,” as FDA sometimes calls it) that FDA already provides under 21 C.F.R. § 20.61(e) when it receives FOIA requests for records containing potentially confidential information.  In short, PDN involves providing an applicant with an opportunity to object on CCI/TS grounds to FDA’s proposed disclosure prior to the records’ release, and if the applicant and FDA do not agree on the scope of disclosure, allowing the applicant a few days before release to seek any emergency relief in court to block it.  See id.

The CP picks up steam as it goes on though, and by its end, it argues that FDA’s “recent release of CRLs for unapproved applications is unlawful and contravenes decades of agency practice with no adequate explanation,” and that “FDA should immediately cease publishing CRLs,” and “at a minimum,” “expeditiously take the steps described herein,” i.e., institute a PDN process.  Tellingly, it “reserv[es] all other rights.”

The Arguments Behind It

The CP makes many legal arguments along the lines we flagged in our earlier blog post, explaining how these CRL releases marked a departure from the agency’s longstanding position and arguing that aspects of them run contrary to disclosure statutes and FDA’s own governing regulations.  We won’t rehash all of that; instead, we’ll provide the top lines on what the CP added beyond what we wrote in our post:

• It squarely argues that these CRL releases violate federal law, including the FOIA, the Trade Secrets Act, and FDA’s regulations. Though it does not specifically accuse FDA of releasing trade secret information in a CRL thus far, it pointedly argues that such a disclosure would also amount to an unconstitutional Taking.
• It asserts that the decision to release these CRLs was “arbitrary and capricious” under the Administrative Procedure Act, because FDA did not acknowledge its change in position, adequately explain it, or consider reliance interests of industry that had come to expect that their information would remain confidential.
• It shares results of the firm’s own research that present a damning picture of FDA’s CRL releases. Most pointedly, it says that out of 127 CRLs for unapproved applications in FDA’s database, there were at least 36 for which the applications had not been previously publicly disclosed or acknowledged, in direct conflict with 21 C.F.R. §§ 314.430(b) and 601.51(b). It then calls out the scope of FDA’s CCI/TS redactions, stating that in almost half of all CRLs released, “FDA did not redact substantive deficiency information,” and explaining in further detail how in 4 of them, “FDA left unredacted detailed and confidential clinical deficiency information that is highly competitively sensitive.”
• It also raises “policy concerns,” arguing that the CRL releases allow competitors to freeride on information that it took the applicant many months or more, at significant cost, to get. Under this view, the benefits FDA touted of helping companies “‘avoid blind alleys and common missteps to accelerate development’” are in fact an admission “that disclosed CRL information will help the applicant’s competitors develop shortcuts.”  The CP also argues that negative publicity from a released CRL could reduce a drug company’s likelihood of continuing to pursue an application if public and/or private support for it wanes, based on a perhaps artificially grim picture the CRL portrays to the outside reader.  (We too previously observed the “one-sided” nature of CRLs.)  All of this, the CP argues, may stifle innovation.
• Finally, it asserts the benefits of PDN in this context, including that it would provide applicants “due process.” It is on shakier ground, however, in arguing that PDN would “reduce burdens for agency employees.”  Because FDA would still be doing the work of proposing redactions in the first instance, and then undergoing PDN’s back-and-forth with applicants who are “familiar with the confidentiality of the information that they generate” and thus “may identify key disclosure issues for the agency to resolve,” these authors don’t see how administrative burdens would be lessened by the exchange.  That said, if the goal here is to help FDA get to the right answer, and not just the fastest or least “burdensome” one, we see their point.

What May Come Next

In our view, the CP raises important considerations that it would be irresponsible for FDA to ignore.  Whether or not these CRL releases ultimately make for good policy, federal agencies must obey federal statutes and their own binding regulations, of course, and at a minimum are not expected to make major shifts in policy without soliciting prior public input.  While this CP comes seven months after FDA began releasing unapproved drug CRLs, it draws from the real world experience of the CRL releases in the intervening time. For example, it provides concrete data on CRLs that marked the first disclosure of an application’s existence and identifies specific instances in which FDA allegedly did not sufficiently redact out CCI/TS in line with governing law (discussions of specific study design deficiencies, endpoints, etc.).  These arguments were foreseeable to us and others back in September, but they now have flesh on the bones.  Finally, the CP (for the most part) offers a modest proposal for the problem: just provide applicants with PDN.

FDA takes a notoriously long time to respond to CPs, as we’ve noted before, and so it may take a while before the agency does anything with this CP.  Still, here are a few possible avenues FDA, and others in turn, might take in response:

• FDA could open a public docket to solicit further input on how to approach this important issue going forward. (Of course, if FDA were to explicitly amend its regulations, it would need to go through notice and comment rulemaking.)  Whether it does that or not, FDA is wholly in control of how and when it releases these CRLs going forward and could simply decide to “immediately” suspend that practice as requested by the CP while it considers the issues it raises — or not.
• Alternatively, other stakeholders may seek to use this already open CP docket to provide their views on the CRL releases now that the can has been opened — for and against. As we mentioned before, many drug companies are likely concerned about the information their competitors could glean from their CRLs, which previously would have been kept confidential prior to approval; but others may consider themselves benefiting on the whole from the increased disclosure by assisting them with their own drug development.  Outside interest groups could be similarly aligned in favor of greater government transparency (and less sympathetic to drug companies’ assertions of the confidential nature of the information).  So it will be interesting to see if this CP itself spurs a more robust public debate on this subject.
• FDA could implement the requested PDN procedures. Not only would this allow an applicant a say in the scope of disclosure before a CRL goes out (and potentially whether it should be published at all), but with prior notice, it would also open a very clear avenue for a company to go to court in a “reverse-FOIA” suit, i.e., one seeking that the agency be enjoined from releasing information before it happens. (We can’t help but note, though, that an applicant who sues to keep the existence of their application hidden would have a trickier go of that through a public lawsuit.)
• And if FDA does nothing, or drags its feet too long, the CP is a clear shot across the bow, containing many arguments that easily could be repurposed into a Complaint suing the agency — whether by this Petitioner or others following its roadmap. Indeed, the CP argues that implementing its proposals “could also help reduce the agency’s litigation risk as well as the risk that FDA employees violate the law — including laws with criminal penalties — in their disclosure practices.” Point made.

We will be keeping a close eye on whether FDA continues along its current path of releasing CRLs notwithstanding this CP; if so, whether a litigation war breaks out; and if so, who will be the first to enter the breach.

Parallel review. Medicare Coverage of Innovative Technology (MCIT). Transitional Coverage for Emerging Technologies (TCET). Each of these initiatives promised to close the persistent gap between FDA marketing authorization and CMS coverage for medical devices. None has fully delivered. Some were formally withdrawn; others simply faded from relevance.

Now comes the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway, announced on April 23, 2026, by FDA and CMS. The agencies promise a program that will deliver “life-saving Breakthrough Devices to American patients as soon as we know they work.” On its face, that is exactly what industry and patients have been waiting for.

But as with all proposals, the details matter—and here, they significantly narrow the promise.

RAPID is not a broadly applicable solution for Breakthrough Devices. Instead, eligibility is tightly constrained. For Class II devices, Breakthrough Device Designation (BDD) alone is not enough—participation in the Total Product Life Cycle Advisory Program (TAP) is also required. Class III Breakthrough Devices are not required to participate in TAP, but all devices must be subject to an Investigational Device Exemption (IDE). That requirement alone excludes non-significant risk devices, which make up the vast majority of devices on the market—particularly within Class II.

The result is a pathway that is, by design, available to only a small subset of sponsors.

Public reporting suggests that CMS estimates approximately 40 currently eligible devices, with perhaps 20 more that could become eligible. CMS has not publicly detailed how it arrived at that estimate, but given RAPID’s criteria, the pool likely consists of:

1. Class II Breakthrough Devices already in TAP that require IDE studies;
2. Class II Breakthrough Devices that could enter TAP and require IDE studies; and
3. Class III Breakthrough Devices that require IDE studies.

Even accepting that estimate at face value, the scale mismatch is striking.

As of December 30, 2025, FDA had granted 1,246 BDDs, with 185 devices having received marketing authorization. That leaves 1,061 devices with BDD that have not yet received marketing authorization. If only 40 to 60 of those ultimately qualify for RAPID, then roughly 1,001 Breakthrough Devices remain without any meaningful acceleration of the coverage pathway.

The numbers underscore a broader concern: RAPID may be less a systemic solution than a targeted pilot for a narrow slice of the market.

To be sure, the program will be valuable for sponsors that qualify. Earlier alignment with CMS and a clearer path to coverage could meaningfully reduce time to patient access for those devices. But tying eligibility to both TAP participation and IDE studies raises an important question—whether the program is built around the devices that most need coverage acceleration, or simply those that are easiest for agencies to coordinate around.

If the goal is to close the FDA–CMS gap at scale, anchoring eligibility to the Breakthrough Device program itself—rather than layering additional prerequisites—would likely have a far greater impact.

CMS is expected to issue a proposed notice in the Federal Register, triggering a 60-day public comment period. Notably, both CMS and FDA have indicated that CMS will respond to comments in the final notice, while FDA’s role in that process remains unclear.

RAPID is a step forward—but a modest one. Whether it becomes more than that will depend on how the agencies respond to stakeholder feedback in the months ahead.

FDA has, once again, reminded sponsors that ClinicalTrials.gov results reporting is not optional.

In a March 30, 2026 outreach, the Agency contacted more than 2,200 sponsors and investigators associated with over 3,000 clinical trials that appear to be missing required results submissions to ClinicalTrials.gov or have not cleared the National Library of Medicine’s quality control process. As FDA put it, these communications were intended to prompt “voluntary compliance” with long-standing statutory and regulatory requirements.

This is not a new obligation, and FDA’s expectations are not ambiguous. Applicable clinical trials—generally interventional studies of FDA-regulated products with a U.S. nexus—must submit results information to ClinicalTrials.gov within one year of primary completion, absent a limited exception. Yet, FDA’s internal analysis indicates that roughly 30% of trials likely subject to these requirements have no results posted.

FDA Commissioner Makary suggested that some sponsors may be intentionally withholding unfavorable results. That may be true in a limited number of cases. But in our experience, reporting delays and failures typically reflect breakdowns in process rather than a nefarious strategy—missed deadlines, personnel turnover, unclear delegation of responsibility for reporting, or even situations in which the original sponsor no longer exists and no clear “responsible party” remains to complete the submission.

That does not make the issue insignificant. Failure to submit required results contributes to an incomplete public record and can skew the available evidence base. That concern is not new, but FDA’s latest outreach suggests that the Agency is taking a more active approach to addressing it.

Procedurally, FDA has several well-established enforcement tools available. The Agency may issue Pre-Notices of Noncompliance (as of the date of this blog, FDA has issued 232 such notices since 2013) and, if necessary, formal Notices of Noncompliance (of which FDA has issued 8 since 2021)  as part of its risk-based compliance efforts related to ClinicalTrials.gov reporting requirements. These actions can lead to additional enforcement consequences, including civil monetary penalties.

What is notable here is that FDA has taken an additional step before initiating those formal processes. The March 30 communications were directed to responsible parties whose trials appear to be out of compliance or delayed in quality control, providing an opportunity to come into compliance before the Agency considers whether to pursue further regulatory action.

This is not the first time FDA has signaled increased attention to ClinicalTrials.gov compliance. As discussed in our prior posts (see FDA Cracks Down on ClinicalTrials.gov Reporting Failures and Court Determines That Decades Worth of Missing Data Must Be Published on ClinicalTrials.gov), both FDA and the courts have, at various points, pushed to address persistent gaps in results reporting—though enforcement has historically been uneven and, at times, dependent on Agency discretion.

The latest outreach suggests that FDA may be taking a more active approach, at least at the front end of the compliance process.

So, what’s the takeaway? FDA seems to be signaling that it is actively reviewing ClinicalTrials.gov compliance and is willing to follow up. If you are listed as the “responsible party,” now is the time to confirm that results have been submitted, that any quality control comments have been addressed, and that responsibility for ongoing compliance is clearly assigned.

It’s been a month since DOJ announced the “first-ever Department-wide corporate enforcement policy” for criminal matters.  Touted as a means of “promoting uniformity, predictability, and fairness” in how DOJ pursues white-collar cases against corporate defendants, the new “Corporate Enforcement and Voluntary Self-Disclosure Policy” (CEP) sets a framework for prosecutors deciding whether to bring, and a roadmap for corporate defendants on how to avoid, federal charges.  Like the other voluntary self-disclosure policies from various DOJ offices and U.S. Attorney’s Offices throughout the country, the Department-wide CEP seeks to incentivize corporate behavior, voluntary self-reporting of potential misconduct, cooperation with law enforcement, and good faith efforts to rectify wrongdoing.

To date, we are aware of just one case in which DOJ applied its new CEP and declined to prosecute a corporation after its voluntary self-disclosure of bribery conduct, which the company had identified during an internal investigation.  While the impact of having a single CEP governing corporate criminal matters is yet to be seen, FDA- and DEA-regulated companies under criminal investigations should seriously consider the benefits of a self-disclosure when it comes to discovery and potential reporting of misconduct.

What Does the CEP Do?

The policy provides a path for declination of a criminal case if the company meets the following factors:

1. Voluntary self-disclosure of the misconduct to an appropriate criminal component of DOJ;
2. Full cooperation with DOJ’s investigation;
3. Timely and appropriate remediation of the misconduct; and
4. There are no aggravating circumstances (e.g. severe harm, recidivism, etc.).

Prosecutors may still recommend a declination in the face of aggravating circumstances, depending on the severity of those circumstances weighed against the other factors.  A company, however, will still be required to pay all applicable disgorgement/forfeiture and restitution to victims resulting from the misconduct.

For those companies that don’t quite meet the criteria for a declination, they still may obtain a non-prosecution agreement (NPA) for a number of years, which is an out-of-court agreement with DOJ to refrain from filing charges, typically in exchange for financial penalties and a tolling agreement.  The CEP states that an NPA may be appropriate where a company’s self-disclosure did not qualify as “voluntary” or where prosecutors determined that the aggravating factors did not warrant a declination.  Full cooperation and timely remediation are still expected, and DOJ may still decide that an NPA is not appropriate if there are “particularly egregious or multiple aggravating circumstances.”

Under an NPA resolution, DOJ may allow a term of less than three years, not require an independent compliance monitor, and provide a 50-75% reduction in the low end of the Sentencing Guidelines fine range.

If a company is ineligible for a declination or NPA under the above framework, prosecutors maintain discretion to otherwise determine an appropriate resolution.  The CEP, however, limits prosecutors’ ability to resolve the monetary penalty of any resolution for less than 50% of the Sentencing Guidelines fine range.

What Do These Terms Mean?

Most of the CEP is really a defining of certain key terms (found in Appendix B of the policy).  These are the details that matter.  The CEP provides the following definitions:

A voluntary self-disclosure is defined as follows:

1. The company makes a good faith disclosure of the misconduct to the appropriate DOJ component;
2. The misconduct is not previously known to DOJ;
3. The company had no preexisting obligation to disclose the misconduct to DOJ;
4. The disclosure occurs “prior to an imminent threat of disclosure or government investigation”; and
5. The company discloses the conduct to DOJ within a “reasonably prompt time” after becoming aware of the misconduct (the burden rests on the company to demonstrate timeliness).

The CEP deems that a company has fully cooperated when it:

1. Timely, truthfully, and accurately discloses all facts and non-privileged evidence relevant to the conduct at issue;
2. Proactively cooperates (i.e., disclosing relevant facts not specifically requested or identifying opportunities for DOJ to obtain evidence not in the company’s possession);
3. Timely and voluntarily preserving, collecting, and disclosing relevant documents;
4. De-conflicting witness interviews and other investigative steps that a company intends to take as part of its internal investigation to prevent conflicting or interfering with DOJ’s investigation; and
5. Makes company officers, employees, and agents available for interviews by DOJ.

Considerations for Industry

The CEP attempts to provide certainty to companies when deciding whether to self-disclose misconduct to the federal government.  But the CEP affords federal prosecutors significant subjectivity in determining whether a corporation has satisfied the factors of “full cooperation” and “timely and appropriate remediation.” Thus it remains unpredictable whether the end result of a self-disclosure will be a declination, a non-prosecution agreement, or subject to prosecutorial discretion.

Further, the CEP is more rigid on whether a disclosure is deemed voluntary.  As noted above, the CEP sets forth five elements in the definition of a “voluntary self-disclosure.”  In contrast, under the Southern District of New York’s policy, which is now superseded by the CEP, a company would have been credited for a voluntary disclosure so long as it had not previously received notice from the government that it was being investigated (e.g., a grand jury subpoena, HIPAA subpoena, or interview request).

Importantly, the CEP does nothing to define timing for the declination decision, unlike the aspirational deadlines set forth in previous voluntary disclosure policies from other offices. While those internal deadlines were not enforceable, companies could point to a written policy requiring at least a provisional response within a certain time period.  As we know, companies (particularly those that are publicly traded) value clarity and transparency, which is one of the missions for the nationwide CEP.

Lastly, companies already operating in an environment that requires reporting certain issues to FDA (e.g., adverse events, recalls) or DEA (e.g., suspicious orders), should be asking themselves whether they should escalate the issue to a voluntary self-disclosure to DOJ.  There can be significant benefit to preemptively reporting an issue before DOJ hears from a whistleblower or is served with a False Claims Act complaint.  And of course there are reasons a company may not want to self-disclose certain issues.  We have advised companies on the pros and cons of self-disclosure, and would be happy to work with you on this analysis if and when it is needed.

As promised and teased in yesterday’s blog post, we discuss other practical implications of and compliance concerns surrounding the ongoing shift in peptide policy below.

Supply Chain Complications

There is also a supply chain issue that sits upstream of any FDA regulatory authorization of their use in compounding.  Pursuant to Section 503A, the bulk API used in the compounding of peptide products must be manufactured at an FDA-registered drug establishment, and accompanied by a Certificate of Analysis.  Similarly, because they are likely sterile injectable products, they should be pharmaceutical-grade.

As the Alliance for Pharmacy Compounding’s (APC) CEO Scott Brunner put it:  Even if FDA acted tomorrow, pharmacies would still have to turn away those prescriptions because they couldn’t acquire the compliant API to prepare the drugs.  Compounding industry representatives have argued that the Agency must provide clearer forward-looking regulatory signals to incentivize the investment in pharmaceutical-grade supply chains.  Without that signal, manufacturers have little economic reason to build the infrastructure the market will need.

The Advertising Question

We bloggers believe one aspect of the potential peptide onslaught deserves mention here.  Even if peptides are finally placed in Category 1, and thus permissible for use in compounding, the advertising landscape will remain significantly constrained.  More specifically, pharmacies, practitioners, and online platforms may not promote compounded drugs using claims of safety or efficacy that otherwise imply FDA approval.  FDA has been unambiguous on this point in the GLP-1 context—issuing over eighty Warning Letters to telehealth companies for allegedly misleading marketing of compounded GLP-1 products in the twelve months ending March 2026—and there is every reason to expect the Agency to apply the same or similar framework to peptide marketing and promotion.  See, for example, FDA’s press release about the issuance of 30 Warning Letters to telehealth companies in early March 2026.  Companies positioning themselves for the anticipated booming peptide market should factor aggressive enforcement of promotional restrictions into their compliance planning from day one.

Industry Is Looking Ahead

APC has publicly supported authorizing production of certain peptides, while emphasizing the need for a pharmaceutical-grade and GMP-compliant API infrastructure first.  And stakeholders planning to weigh in have until July 9, 2026, to submit written comments to the docket (FDA–2025–N–6895); those interested in making oral presentations must notify FDA by June 30, 2026.

The Bottom Line

The peptide compounding policy environment is shifting—but deliberately and incrementally, not overnight—and likely too incrementally for those compounders ready to start dispensing peptides now.  The Category 2 removals and the ensuing July 2026 and early 2027 Pharmacy Compounding Advisory Committee (PCAC) meetings are seemingly meaningful procedural steps, and the political momentum behind this shift is real.  That said, compounders and industry participants should plan around a realistic timeline:  While there may be an interim period of enforcement discretion that may be announced by FDA around the time of the PCAC meetings, final rulemaking, if it proceeds smoothly, is still likely more than a year away; pharmaceutical-grade API supply chains need to be developed in parallel; and promotional restrictions will remain stringent regardless of what happens to the 503A list.

For companies with commercial interests in this space—whether compounding pharmacies, telehealth platforms, API manufacturers, or investors—this is a moment to evaluate the shifting regulatory landscape, and engage carefully and thoughtfully.  That may mean submitting comments to the docket, fostering supply chain and laboratory testing relationships, and/or designing marketing strategies with FDA’s promotional framework squarely in view.  The window for unregulated gray-market peptides may be closing, but the window for regulated compounded peptides is not yet fully open—and getting there likely will require navigating a more complex regulatory process than the current headlines or political/public fervor may suggest.

We will continue to monitor and report on developments in the peptide compounding space.

The Byrds was one of my favorite bands growing up.  I find much of their music fresh and timely today due in no small part to Roger McGuinn’s trademark jingle-jangle on the Rickenbacker twelve-string guitar.  The Byrds’ version of Pete Seeger’s “Turn! Turn! Turn!” reached Number One on the Billboard charts in December 1965.  Seeger took the lyrics, ascribed to King Solomon in the 10^th Century B.C., from the Book of Ecclesiastes, thereby giving the Byrds recording of the song the distinction of being the Number One Billboard hit with the oldest lyrics.

For those unfamiliar, the powerful song’s theme is that there is a season and a time for everything: a time to be born, a time to die; a time for war, a time for peace.

However, an updated version of the lyrics might include the timely line:  “A time to cast away meds, and a time to gather meds together.”

Which segues us lyrically to the Drug Enforcement Administration’s (“DEA’s”) 30^th National Prescription Drug Take Back Day.  Unwanted and expired controlled prescription medication languishing in medicine cabinets are prime candidates for theft, misuse and abuse.  DEA and its law enforcement partners will once again host about 4,200 local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, April 25th, from 10:00 a.m. to 2:00 p.m. local time.

DEA holds the ever-popular drug take back event each spring and autumn.  Last October’s Take Back Day collected over 571,000 pounds, or 286 tons, of unneeded medication at 4,263 collection sites nationwide.  DEA has collected over 20.3 million pounds, or 10,196 tons, of unneeded medication since 2010.  Additional information about National Prescription Drug Take Back Day, including disposal locations, can be found at: https://www.deadiversion.usdoj.gov/drug_disposal/takeback/takeback.html.  DEA’s Diversion Control website also lists permanent year-round drug disposal locations and provides other disposal information.

So, in the spirit of an updated “Turn! Turn! Turn!,” we’ve gathered meds together, but now its time to cast them away.

The peptide compounding landscape shifted last week, and if you are interested or involved in the peptide industry, compounding pharmacies, telehealth, or the broader market for injectable wellness products, you’ll want to understand what happened—and perhaps more importantly, what hasn’t happened yet.

FDA’s PCAC Meeting Announcement

We have been waiting for some type of “peptide announcement” from FDA/HHS—at least since HHS Secretary Robert F. Kennedy Jr.’s  appearance on the Joe Rogan podcast. (Yes…the senior blogger on this post now gets her breaking FDA/HHS news from her 28 year-old son and a Rogan podcast regular listener).

Then, on April 16, 2026, FDA published a Federal Register notice announcing a Pharmacy Compounding Advisory Committee (PCAC) meeting scheduled for July 23-24, 2026, at FDA’s White Oak Campus in Silver Spring, Maryland.  The PCAC will consider seven peptides for potential inclusion on the Section 503A Bulk Drug Substances List:

• On July 23^rd: BPC-157, KPV, TB-500, and MOTs-C
• On July 24^th: Emideltide (DSIP), Semax, and Epitalon

The specific indications under review range from ulcerative colitis and wound healing to opioid withdrawal, cerebral ischemia, and insomnia.  FDA also announced the PCAC will convene again before the end of February 2027 to review five additional peptides for the 503A Bulks Drug Substances List, including GHK-Cu, Melanotan II, Cathelicidin (LL-37), Dihexa acetate, and Mechano Growth Factor, Pegylated (PEG-MGF).

In parallel, FDA updated its 503A bulk substance categories to reflect that the peptides under consideration would be removed from Category 2 within seven calendar days.  Taken together, these moves signal that the 19 peptides that were moved to Category 2 in 2023 during the Biden administration’s “are potentially moving to some form of regulated access—though the road from here to there is longer than some headlines may suggest.

And, please don’t forget, lest you are as confused as we were by Secretary Kennedy’s recent testimony here (starting around the 2:16:32ish mark), these peptides to be considered by the PCAC, were never on “Category 1,”  which of course is the list of substances that may legally be used in Section 503A compounding if they are not a component of an FDA-approved drug or the subject of a USP/NF monograph.  Of note, FDA has also been interestingly silent concerning Section 503B outsourcing facilities’ ability to compound using peptides—FDA has not indicated that these 12 peptides will be reviewed for or otherwise moved to the Agency’s separate 503B Category 1 list.

How’d we get here?

To understand where we are, it helps to recall where we’ve been.  In September 2023, FDA moved over a dozen peptides into Category 2 of the 503A bulks list:  a designation that effectively prohibited their use in compounding.  But note again, these peptides were never listed in Category 1 and thus could not be legally used in compounding.

The Agency cited “significant safety concerns” for these popular peptides, including risks related to immunogenicity, impurities, and availability of only limited human clinical data.  That decision did not eliminate demand for these products—it likely just redirected it.  Next, FDA was sued by Evexias and Farmakeio down in Texas under the Administrative Procedure Act, citing a lack of transparency concerning the placement of certain peptides in Category 2.  That lawsuit dealt specifically with four peptides:  AOD-9604, CJC-1295, Ipamorelin acetate, and Thymosin Alpha-1 (“Ta1”).

Tweeting since 2024, Secretary Kennedy has made reversing this “policy” a public priority, citing the “black market” prior restrictions and framing the current shift as an effort to “restore” regulated access for patients and providers.  For a third time, they were never legally permitted under 503A.  Secretary Kennedy has discussed the issue extensively in public media appearances, and his interest in the issue—and a history-remaking advisory committee process—has not gone unnoticed by stakeholders closely watching the PCAC’s composition.  The committee currently sports a roster of only three voting members, one industry liaison, and no chair, against an authorized slate of up to twelve voting members.  Some observers have noted concerns that the PCAC’s makeup could be shaped by political appointments before the July meetings, though there is no indication that has occurred.

See our long and winding coverage of the rollercoaster ride that has been the 503A bulks list here, here, here, here, here, here, here, here, and here.

Why the PCAC Meetings Matter—and What It Doesn’t Do

Let’s be clear:  The July 2026 meeting is likely a necessary procedural step, not the finish line.  Under FDA’s typical process, changes to the 503A Bulk Drug Substances List are routed through the PCAC; without such a review, any modification would likely face a legal challenge.  Notably, PCAC’s recommendation is non-binding, and formal rulemaking is what comes next.  Even if PCAC recommends adding these peptides to 503A’s “Category 1” list, and even if FDA agrees, notice-and-comment rulemaking is still required—a process that, under standard timelines, can take more than a year.  Given the bulks list final rulemaking that has not yet occurred under Section 503A, other than for about ten substances, the process could take a very long time.  For industry participants planning product or service launches around peptide compounding, that timeline is important to internalize.  If indeed FDA decides to place these peptides in Category 1, then the Agency should include them in Category 1 on an interim basis, as that has been FDA’s policy since the passage of Section 503A in 1997 and the Drug Quality and Security Act in 2013.

And, Secretary Kennedy, with the stroke of the pen, arguably could determine to place the referenced peptides in Category 1, and permit immediate legal access, given that Section 503A(c) states, “the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health.” (Emphasis added.)  While one could consider that such a provision would only be invoked to remove unsafe substances, Secretary Kennedy arguably could use this provision to place these peptide substances in Category 1 in the “interest of public health,” or more specifically, to shut down the fast-growing gray/black peptide market.

Notwithstanding, moving peptides to Category 1 poses other issues and questions.  We will discuss those in our post tomorrow, so stay tuned.

The GLP-1 market is set to hit over $30 billion by 2030.  Intellectual property litigation and FDA crackdowns have led to a boom in M&A and partnership activity.  Long-term patient effects have yet to be fully realized.  The future of GLP-1s is bright, but ownership, liability, and regulatory priorities still hang in the balance.  That’s the backdrop for the American Conference Institute’s (“ACI”) 2nd Annual Summit on GLP-1 Law & Policy, which returns on June 4, 2026, at 3 Times Square, New York, NY.

ACI’s distinguished faculty of in-house counsel, representing innovators, compounders, providers, and more, alongside outside counsel with a bird’s-eye view, will spend one jam-packed day discussing the full spectrum of legal and regulatory challenges and market concerns facing the GLP-1 drug industry.  The conference will address everything—state and federal regulatory activity and FDA; advertising challenges across the media landscape; intellectual property disputes beyond the patent; mass torts and pharmacovigilance; the peptide boom and new market innovations; and more!

Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer, along with Peter Pitts, President and Co-Founder of the Center for Medicine in the Public Interest, will co-present at a session titled “Prognostication Station: Anticipating the Long Tail of the GLP-1 Market.”  The session will consider the GLP-1 market as it exists today, and ponder what to expect for GLP-1 legislation, regulation, and litigation over the next 6 months, one year, five years, and beyond.

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA26. You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference.

As any well-rounded consumer of television knows, one of the most ubiquitous tropes in sitcoms is the “will they-won’t they” dynamic.  Take your pick:  Ross and Rachel from Friends, Jim and Pam from The Office, or Mulder and Scully from The X-Files.  It’s riveting and exhausting.  FDA has grown similarly tired of Congress’s will they-won’t they decision-making when it comes to the reauthorization of the Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) program.

In its FY2027 budget request (at 27), FDA has requested that Congress make the RPD PRV program permanent.  This proposal would end the familiar four-year reauthorization cycle that has repeatedly put the program at risk of lapsing and, from industry’s perspective, would provide much-welcomed and needed predictability for sponsors developing therapies for children with serious or life-threatening rare diseases.

First, a Quick Refresher on the RPD PRV Program

Section 529 of the FD&C Act authorizes FDA to award a priority review voucher to sponsors of certain approved rare pediatric disease products.  A voucher allows the holder to redeem priority review for another application, shortening FDA’s review clock from the standard 10 months to 6 months.  Therapies that are eligible to receive an RPD PRV must contain a new active moiety and target a serious or life-threatening rare pediatric disease, among other things.  See FDA’s dedicated website, Rare Pediatric Disease Designation and Priority Review Voucher Programs, and draft guidance, “Rare Pediatric Disease Priority Review Vouchers.”  The vouchers are transferable and can be extremely valuable—often selling for hundreds of millions of dollars—creating a financial incentive to invest in treatments that might otherwise be commercially challenging or unviable.  To demonstrate the potential financial windfall these vouchers can bring, look no further than Cyprium Therapeutics.  The Fortress Biotech Inc. subsidiary recently sold its RPD PRV for $205 million.

Historically, Congress has reauthorized the program every four years.  That cadence has created recurring uncertainty; the program even briefly expired in 2024 before being renewed again this past February via the Consolidated Appropriations Act of 2026.  See our previous blog post here.  If nothing changes, it is currently set to expire in September 2029.  See our previous coverage of the program’s recent tumultuous, uncertain status and ultimate reauthorization here, here, here, and here.

Why does FDA want Permanence?

I mean, who wouldn’t?  Have you ever heard of a professor turning down tenure or the Harlem Globetrotters losing to the Washington Generals?  Everyone wants a sure thing.  Note:  Please don’t email the authors about the Globetrotters’ 1971 loss to the New Jersey Reds, the predecessors to the Generals—no one likes a know-it-all.

Kidding aside, permanent authorization would prevent future cliffhangers tied to the congressional budget cycle and help ensure that children with debilitating or life-threatening conditions continue to gain access to new therapies.  We saw many of our own clients face struggles in receiving infusions of investment for continued development as the prior September 2026 sunset loomed.  Sadly, certain applications were submitted more rapidly and perhaps without the degree of prior FDA interaction that would be typical to consider data from a rare disease setting, in order to have their NDA/BLA action date fall ahead of the sunset.  Whether early in development or even at completion, the sunset of this vital program had a ripple effect across industry.

What You Should be Watching?

Permanent reauthorization would mark a significant policy shift for a program that has long lived on periodic congressional renewals.  For industry, it could reduce regulatory uncertainty and strengthen incentives for rare pediatric drug development.  Drug development requires long-term investment with a 10-15 year runway to get from bench to bedside.  The potential for PRV eligibility is important to secure investment that allows products to get licensed from researchers to move into GLP toxicology studies and then into first-in-human clinical trials, and remains an important factor for advancing products through each phase of development.  Development of drugs for rare diseases already is a challenging case to make when the development paths are typically so uncertain themselves with equally uncertain regulatory acceptance.  This is why having a certain regulatory/developmental “carrot” in the RPD PRV program is so important.

For Congress, however, it raises the perennial question of whether the PRV model is delivering sufficient public-health return on investment.

As the FY2027 budget process unfolds, stakeholders across the rare disease landscape will be watching closely to see whether the RPD PRV program finally escapes the reauthorization cycle—or faces another cliffhanger countdown to expiration.

We will continue to monitor FDA’s budget requests and report back on any developments.

If you’ve been tracking FDA’s international presence, you know FDA has been through a bit of a roller coaster over the past decade.  After consolidating from 13 foreign offices down to 8 between 2012 and 2014—and losing its Pretoria, South Africa office in 2015—the Agency is now back in expansion mode.  And the latest moves are worth paying close attention to if your products are manufactured or sourced overseas.  For a general overview of FDA’s purpose behind and process for choosing foreign offices, see the Agency’s 2012 Report to Congress on the FDA Foreign Offices.  The Government Accountability Office (GAO) has also issued several reports related to improvements needed at FDA’s foreign offices to support inspections of foreign food (2015) and drug (2016 and 2022) facilities.

What FDA is Proposing

FDA’s FY2027 budget request includes an additional $2.5 million and five new full-time equivalent employees dedicated to opening two new foreign offices—one in Hanoi, Vietnam, and one in Tokyo, Japan.  These offices are expected to conduct both food and medical product inspections, and the Agency frames the investment explicitly around strengthening global competitiveness and inspection capabilities.

These moves aren’t coming out of nowhere.  Both offices were already funded in the FY2026 FDA appropriations bill, and the Senate’s accompanying joint explanatory statement specifically called for the agency to build a permanent presence in East Asia—including Tokyo and Hanoi—to conduct traditional and unannounced inspections.  Senators also signaled a desire for FDA to beef up regulatory control over devices, drugs, and aquaculture products coming out of the region.  The FY2027 request is essentially the next step in turning that congressional aspiration into reality.  Separately, the FY2027 budget request also includes $9 million to “increase foreign inspection capacity.”

Why These Locations?

Tokyo might raise some eyebrows.  Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is widely regarded as one of the most sophisticated drug regulators in the world—on par with FDA and the European Medicines Agency.  So why plant a flag there?

A few reasons are worth considering or at least speculating upon.  First, Tokyo is geographically well-positioned as a hub for broader regional access across Asia.  Second, there’s a growing U.S.-Japan regulatory collaboration story here—PMDA opened its own office in Washington, D.C. in 2024 to deepen ties with U.S. regulators and help companies navigate its market.  An FDA presence in Tokyo could reciprocate and strengthen that relationship.

Hanoi, in our opinion, is a more straightforward choice.  Vietnam has become a significant and growing source of drugs and other products imported into the United States (see here), and closer on-the-ground inspection capacity there makes clear operational sense.  Imports of FDA-regulated products from Vietnam have increased significantly in recent years.  In FY2015 there were just shy of 96,000 lines of product imported from Vietnam, but by FY2025 that number had increased tenfold to over 961,000 lines.  What is being imported from Vietnam has also changed significantly:  in FY2015 the vast majority (~70%) of those imports were human foods, but, by FY2025, 60% of those imports were medical devices (see FDA Data Dashboard, Imports Summary).  The Senate’s specific mention of aquaculture products—a major Vietnamese export—signals that Congress also has that supply chain squarely in its sights.

Not As Simple As Writing a Check

It’s worth noting that opening foreign offices involves more than budgeting the funds.  As we’ve covered previously, FDA has long struggled with vacancies in its existing foreign offices.  As described in the 2022 GAO Report detailing improvements needed to FDA’s foreign drug facility inspection, FDA has had difficulty recruiting qualified staff to foreign offices and, once a qualified candidate is selected, it can take an additional 9-12 months to complete the “security and medical clearances and other prerequisites” needed to work overseas.  FDA learned this lesson the hard way in 2013 and 2014 when the Agency spent months waiting on visas just to staff its China office.

So, while the funding request and congressional support are positive signals, companies shouldn’t expect these offices to be operational overnight.

The Bigger Picture:  FDA’s Expanding Foreign Footprint

The Tokyo and Hanoi offices are part of a broader pattern of FDA re-engagement internationally.  The Agency currently operates seven foreign offices—in Mexico, Costa Rica, Chile, Belgium, Rwanda, India, and China—and, as evidenced by this blog post and other indicators, is actively working to add more.  The Belgian office includes a staffer embedded with the European Medicines Agency in the Netherlands and the Rwanda location in the African Medicines Agency Liaison Office.

A Middle East office is also on the way.  The Give Kids A Chance Act (see our previous post here), enacted earlier this year as part of appropriations legislation, mandated that FDA establish a presence in a country that signed the Abraham Accords—which includes Israel, the UAE, Bahrain, Morocco, and Sudan—by January 2028.  Agency officials are still conducting consultations to determine the specific location, and it’s unclear whether this timeline remains on track.

On the other hand, a planned office in Brasilia, Brazil appears to have stalled.  FDA had signaled interest in a Brazil office as recently as 2024, but it’s no longer listed among the Agency’s active foreign office plans.

What This Means for Industry

For companies with manufacturing operations or supply chains in East Asia—particularly in Vietnam and Japan—the regulatory trajectory is clear:  FDA intends to have a more persistent, on-the-ground presence in your backyard.  That means greater capacity for unannounced inspections, faster response to emerging compliance issues, and less reliance on headquarters-managed oversight from the White Oak facility in Maryland.

If, for example, your supply chain runs through Vietnam or involves Japanese contract manufacturers, now is a good time to review your inspection readiness, as well as the readiness of your CMOs and critical suppliers.  FDA’s foreign offices have historically served as force multipliers for the Agency’s inspection program, and there’s no reason to expect the Hanoi and Tokyo outposts to be any different.  HPM regularly provides inspection readiness training to foreign and domestic manufacturers and can assist with CMO Quality Agreements to ensure responsibilities are clearly allocated in advance of an inspection.

The bottom line:  FDA is investing in its ability to see what’s happening at the source—and that investment is coming to East Asia.

On April 7, 2026, FDA’s Center for Devices and Radiological Health (CDRH) announced the READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home, part of its broader Home as a Health Care Hub initiative. The program is intended to accelerate patient access to medical devices that support post-discharge care and reduce hospital readmissions.

For device developers, the Challenge offers a new pathway for early and iterative FDA engagement. At the same time, it highlights ongoing tensions in FDA’s regulatory approach to home-use technologies, particularly for diagnostic and specimen collection devices.

Program Overview

The READI-Home Innovation Challenge is designed to promote development of devices that enable monitoring, treatment, and recovery in the home in order to reduce hospital readmission rates, with a focus on technologies used by patients and caregivers rather than healthcare professionals.

The program includes two phases:

• Selection Phase (April 7 – September 30, 2026):
  Sponsors submit an informational Q-Submission describing the device, development status, and anticipated clinical impact.
• Interaction Phase (beginning December 5, 2026):
  Up to nine selected devices (no more than one per manufacturer) will receive enhanced FDA engagement, including “sprint”-style discussions and more frequent feedback on device design and testing for home use.

Submission Expectations

Submissions are limited to 16 pages (including a one-page executive summary, exclusive of references) and must address:

• Device description and clinical need;
• Novelty of the device;
• Current development status of the device;
• Data development plan, including information for both clinical and non-clinical completed and planned testing;
• Team expertise; and
• Anticipated impact, specifically, how the device is expected to significantly improve the benefit-risk profile of a treatment or diagnostic compared to alternatives for the identified disease or condition.

FDA will prioritize devices that:

• Address unmet needs in the home setting;
• Are intended for patient and/or caregiver use;
• Can be deployed by the patient without continuous clinical supervision;
• Have supporting evidence suggesting potential to reduce readmissions; and
• Have sufficient evidence to demonstrate feasibility.

Key Takeaways for Sponsors

1. Earlier FDA Engagement

The Challenge provides a structured opportunity for early interaction with FDA. Sponsors should be prepared to engage with a well-developed regulatory and evidence strategy, including a clear articulation of how the device may impact readmission rates.

2. Increased Focus on Home-Use Considerations

Devices will be evaluated through a home-use lens, presumably with an emphasis on:

• Human factors and usability
• Labeling and instructions for lay users
• Performance in uncontrolled environments

3. Opportunity to Align with Expedited Programs

Participation may facilitate consideration for programs such as the Breakthrough Devices Program or Safer Technologies Program (STeP), creating potential downstream regulatory advantages.

A Broader Regulatory Tension

The READI-Home Innovation Challenge reflects FDA’s growing emphasis on expanding care delivery in the home and supporting innovation in this space. However, it also underscores an ongoing challenge for sponsors: inconsistent application of regulatory flexibility across categories of home-use devices.

In particular, developers of home specimen collection and diagnostic devices have continued to face significant evidentiary expectations, driven by concerns regarding variable home environments and lay user performance. These expectations often translate into extensive usability, stability, and method comparison data requirements.

While FDA has emphasized its commitment to the statutory “least burdensome” standard, there remains limited guidance on how that principle is applied in the context of home-use diagnostics.

Conclusion

The READI-Home Innovation Challenge presents a valuable opportunity for device developers to engage early with FDA and shape regulatory strategy for home-use technologies aimed at reducing readmissions.

At the same time, sponsors should be aware that regulatory expectations for home-use devices remain complex and, in some areas, evolving. Careful planning—particularly with respect to clinical evidence, human factors, and real-world use conditions—will be critical to success.

How We Can Help

We can assist clients in preparing their submissions for the READI-Home Innovation Challenge, developing regulatory and clinical strategies for home-use devices more broadly, and assessing eligibility for FDA programs such as the Breakthrough Devices program or STeP.

Please contact us if you have questions about the READI-Home Innovation Challenge or would like assistance preparing a submission.

With the Quality Management System Regulation (QMSR) compliance date of February 2, 2026, FDA has been convening a series of town hall discussions to help industry with compliance.  In our previous post we discussed FDA’s final town hall prior to the compliance date and the Agency’s emphasis on risk, design, and culture of quality.  On April 1, FDA held another town hall that reviewed the updated Inspection of Medical Device Manufacturers Compliance Program Manual (CP-7382.850) (the CP), which we blogged about previously.

In the opening remarks, FDA summarized the two inspection models and noted that unlike prior inspections under the Quality System Inspection Technique (QSIT) that each inspection will include evaluation of each area of a company’s Quality Management System (QMS).  After the summary, FDA turned to a panel of experts who responded to frequently asked questions related to FDA inspection under QMSR and the new CP.

There were several points made by the panel that are worth highlighting.

Risk-based approach

FDA noted that while they previously requested risk management (RM) documentation during QSIT inspections, under QMSR inspections they will emphasize RM documents and risk controls throughout the QMS. During inspections, FDA will review RM files and reports for products, risk analysis (hazard/harm), documentation showing how risk controls are implemented, and documentation to show risk controls are effective.

When asked about methodology to assess risk in different areas of the QMS, FDA noted that different processes carry different levels of risk and that manufacturers can use different RM approaches as long as the approach used is appropriate for risks involved and risk-based decisions are documented in the QMS.  FDA stated that the risk-based approach for administrative processes, such as document control or training,  is different from the formal risk process used to evaluate product risk under clause 7.1 of ISO 13485.  FDA noted that manufacturers will not need separate risk assessments for administrative processes.  Instead, when making decisions, manufacturers should reference risk documents related to the product.  As an example, FDA noted that risk documentation related to the manufacturing process may be used to determine training frequency.  FDA did not, however, explain what happens when an entity is not the owner of the product risk documentation.  For example, when the establishment is the contract manufacturer and does not own the design or it is merely the initial importer.  As with other town halls, FDA did not take questions from the audience during this one either.

Inspection Technique

FDA noted that the inspection process will be largely the same under the CP as it was under QSIT, though there are some notable differences.  What isn’t changing is that investigators will still provide a Form 482, tour the facility, ask to see how products and processes work, ask about roles and responsibilities, review quality data and documents, observe and watch processes in action, and issue a Form 483 for any inspectional observations, which can be annotated or responded to in writing after the inspection.  Specific documents and evidence reviewed will continue to depend on the risk of the device and priorities for the inspection, and the threshold for compliance action has not changed.

One difference in inspections under the CP is that a statistical sample, as used in QSIT inspections, is not required.  Investigators will conduct record review as they deem appropriate, with the number and type of records being selected based on product risk, and the investigators’ experience and professional knowledge.

As noted above, unlike QSIT inspections, each Model 1 or Model 2 inspection under the CP will evaluate all applicable QMS areas and Other Applicable FDA Requirements, with Model 1 inspections evaluating at least one element in each area and Model 2 inspections evaluating all elements.  FDA noted that in Model 1 inspections, the number of elements reviewed is the minimum and is flexible, allowing inspectors to expand as needed in accordance with a risk-based approach.  FDA noted that investigators will typically cover more than one element to ensure risks are controlled.

QMSR inspections will now include review of management review, internal audits, and supplier audits, which were out of scope in previous inspections under the Quality System Regulation.  When asked how far back inspectors will look at records for management review and audits, and what guidance inspectors are given for review of these new record types, FDA noted that for baseline inspections and pre-approval inspections, these records will be specifically requested.  In other inspections, FDA expects to use their findings to determine when to review these records.  For example, if the inspection identifies issues in design, the inspector may look at how internal audits have evaluated design.

FDA additionally commented that inspections will not follow the Medical Device Single Audit Program (MDSAP) approach and that there are no additional guidance documents planned to support the CP.

Culture of Quality

In prior town hall discussions, FDA emphasized the need for a culture of quality.  When asked how to demonstrate a culture of quality, FDA stated there are no special steps to document quality culture – it is reflected in decisions made and actions taken throughout the QMS.  FDA investigators will look at how manufacturers operate and make risk-based decisions.

FDA also noted that the manufacturers should ensure the internal audit program is evaluating how risk management is integrated throughout product development, how a risk-based approach is used throughout the QMS, and how risk controls are implemented in each impacted process.

FDA’s most recent QMSR town hall discussion provided valuable insight into how inspections will be conducted and where investigators will focus their attention. While many elements of QMSR inspections will feel familiar, the shift toward evaluating the entire QMS, the increased emphasis on risk management integration, and the broader discretion afforded to investigators represent meaningful changes that manufacturers should not underestimate.

Last week, FDA released its Justification of Estimates for Appropriations Committees for the Agency’s Fiscal Year 2027 (“FY2027”) budget request.  Prior budget requests included a separate document titled “FDA Legislative Proposals” (see, e.g., here, here, here, and here; and our prior post here).  The FY2027 budget request incorporates them into the broader Justification of Estimates for Appropriations Committees document (Pages 16-27).  But that’s not the only difference this year compared to prior years.  For FY2027, FDA’s budget request includes a whopping 27(!!) legislative proposals.  Here’s the run-down:

1. Holding Firms Accountable Using Misleading Advertising to Drive Profits at the Expense of Consumers
2. Strengthening Oversight of Critical and Other Foods to Better Protect Infants and Children
3. Allow Companies Manufacturing Generic Medications Domestically to File Paragraph IV Certifications Earlier, Giving Exclusivity Rights to US Manufacturers
4. Ensure FDA Access to Industry Data to Strengthen Food Chemical Safety
5. Allow Disclosure of Certain Information in Complete Response Letters
6. Require Destruction of Imported Products that Pose a Significant Public Health Risk
7. Create Efficiencies for Review and Approval of Biosimilar Applications and Deem that Approved Biosimilars are Interchangeable
8. Increase Agency Flexibility Regarding the Convening of Advisory Committees and the Composition of Such Committees
9. Strengthen Enforcement Against Importation of Unauthorized Electronic Nicotine Delivery Systems (ENDS) and Other Illegal Tobacco Products
10. Mutual Recognition Authority for Bioresearch Monitoring Inspection
11. Collect Foreign Food Facility Registration Fees
12. Create an Additional Abbreviated Licensure Pathway for Biological Products
13. Explicitly Address Generic Drug-Device Combination Products
14. Clarify When Patent Information Must Be Submitted for a 30-Month Stay to Be Available
15. Creating Parity Between Nicotine and Nicotine Analog in Statute
16. Require Retention of Data and Records Supporting Marketed Medical Products and Marketed Medical Product Applications and to Address Fraudulent Data
17. Authorize the Disclosure and Use of Certain Information Related to Impurities in Drugs That Pose a Risk to Human and Animal Health
18. Postapproval Quality Updates
19. Modernizing the Requirements in BPCA and PREA for Agency Review of Pediatric Postmarket Safety Reporting
20. Share Food Safety Information with State, Local, Tribal, and Territorial Authorities
21. Disrupt the Flow of Problematic Imported Medical Devices
22. Clarify FDA’s Enforcement Authority Regarding Manufacturing Changes to Approved Drugs and Biological Products
23. Align the FD&C Act with Longstanding Timelines and Procedures Governing Application Reviews and Streamline Appeals When an application is Not Approvable
24. Provide Medical Assistance and Evacuation Insurance for Food and Drug Administration (FDA) Employees
25. Create a new Clinical Trial Notification Pathway to Serve as an Alternative to the Burdensome Existing Investigational New Drug Pathway to accelerate drug development timeline to Make America Healthy Again
26. Give FDA significant enforcement authorities, including civil monetary penalties and the authority to pull products off of market if active pharmaceutical ingredient source data is not reported.
27. Permanently authorize the rare pediatric disease priority review voucher program and related user fees.

Some of these proposals are of greater interest to this blogger than others, given my focus on the Hatch-Waxman Amendments and the Biologics Price Competition and Innovation Act (“BPCIA”).  To that end, lets take a closer look at certain FY2027 Legislative Proposals (the full legislative proposals are in italicized typeface below):

Allow Companies Manufacturing Generic Medications Domestically to File Paragraph IV Certifications Earlier, Giving Exclusivity Rights to US Manufacturers

This proposal would amend current law to allow domestic generic drug manufacturers to submit Abbreviated New Drug Applications earlier than foreign manufacturers in certain circumstances, which may help repatriate the U.S. pharmaceutical supply chain by making domestic generic drug manufacturers more likely to be eligible for 180-day exclusivity. The proposal would amend section 505(j)(5)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act) to allow generic companies based in the U.S. that currently manufacture a generic drug in the U.S. or are making investments in new domestic manufacturing facilities to substantially increase manufacturing capacity of a generic drug in the U.S., to file their application and paragraph IV certification(s) on the timeline currently codified in section 505(j)(5)(F)(ii) of the Act, and delay by one month when other companies can file their application and paragraph IV certification(s).

Ohhhh. . . .  This is a nice idea, and somewhat similar to one idea that this blogger has promoted for years as a “Made in the USA” or “First Applicant Prime” generic drug incentive (though usually in the form of additional or separate exclusivity, which Congress should consider given how watered-down 180-day exclusivity has become).  Under this proposal, generic drug manufacturers who meet certain “America First” prerequisites would be the only ANDA applicants that can qualify for 180-day Paragraph IV exclusivity for some drug products by virtue of being allowed to submit on the so-called NCE-1 date, while other, “non-America First” ANDA applicants would need to wait a month (a new “NCE-1+1 month” scheme).

Create Efficiencies for Review and Approval of Biosimilar Applications and Deem that Approved Biosimilars are Interchangeable

This proposal would streamline the review and approval of biosimilars by amending section 351 of the Public Health Service (PHS) Act to no longer include a separate statutory standard for a determination of interchangeability and deem all approved biosimilars to be interchangeable with their respective reference products. A determination of interchangeability pertains to pharmacy substitution of an interchangeable biosimilar for its reference product without the intervention of the prescribing health care provider. The statutory distinction between biosimilar products and interchangeable biosimilar products has led to confusion and misunderstanding, including among patients and healthcare providers, about the safety and effectiveness of biosimilars and about whether interchangeable biosimilars are safer or more effective than other biosimilars. Both biosimilars and interchangeable biosimilars are just as safe and effective as their respective reference products and can be used in place of their respective reference products. This proposal would make the U.S. biosimilar program more consistent with current scientific understanding, as well as with the approach adopted by other major regulatory jurisdictions such as the European Union that permit interchangeability of biosimilars with their respective reference products upon approval, thus making the US biosimilar market more competitive with our European counterparts and lower costs for consumers. 

This proposal would also create a presumption that a comparative clinical study that includes the assessment of efficacy is unnecessary to support a demonstration of biosimilarity upon a prospective applicant’s written request, unless FDA provides a justification within an agreed-upon time period as to why such study is necessary or why additional scientific information is needed for the determination. This would further streamline biosimilar development programs, where scientifically appropriate, and provide additional clarity to prospective applicants about the type(s) of assessments that are necessary to support a determination of biosimilarity for specific biological products. 

This proposal would also amend the PHS Act to remove the requirement in section 351(k)(5)(B) that biosimilar applications specifically be reviewed by the review division responsible for the review and approval of the reference product application. This change will increase the efficiency of the review of biosimilar applications by allowing the FDA to concentrate all biosimilar reviews in a single review division that specializes in biosimilar review and licensure.

This legislative proposal would codify FDA’s evolved position on biosimilars—and interchangeable biosimilars in particular—since the March 23, 2010 enactment of the BPCIA.  We’ve seen the most dramatic change within the past year as FDA accelerates incremental policy changes that reduce testing requirements and effectively erases the distinction between “highly similar” and “interchangeable” biosimilar biological products.

In 2010, there was no then-currently scientific, regulatory, or medical consensus regarding the data needed to show that a proposed biosimilar can be expected to produce “the same clinical result as the reference product in any given patient”—the statutory standard for biological product interchangeability.  42 U.S.C. § 262(k)(4)(A).  As a result, FDA initially recommended dedicated switching studies to support interchangeability.  In addition, comparative efficacy studies were the norm to demonstrate biosimilarity for both “highly similar” and “interchangeable” biosimilars.

But given both the precision of current analytical methods and accumulating experience showing that the risk from reference product and interchangeable product switching is insignificant, FDA’s thinking has evolved.  Today, clinical switching studies are generally no longer needed to demonstrate interchangeability; nor are comparative efficacy studies the norm for demonstrating biosimilarity, but rather a comparative analytical assessment of certain attributes.  Thus, FDA’s  requirements for demonstrating biosimilarity and interchangeability are, for practical purposes, the same for both statutory categories of biosimilars (at least for therapeutic protein products), and the line between “highly similar” and “interchangeable” biosimilar biological products is blurred nearly beyond recognition outside of the outdated statutory bifurcation.

A version of this legislative proposal is already pending in Congress: The Biosimilar Red Tape Elimination Act (S. 1954 & H.R. 5526).

Create an Additional Abbreviated Licensure Pathway for Biological Products

This proposal would amend section 351(a) of the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are intended to differ from an FDA-approved biological product, but for which scientifically justified reliance on FDA’s previous determination of safety, purity, and potency for a biological product and/or on published literature would enable a more streamlined and efficient development program. The proposed abbreviated licensure pathway would be conceptually similar to the pathway for follow-on drug products in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which expressly allows an applicant to rely for approval on investigations that were not conducted by or for the applicant (and for which the applicant has not obtained a right of reference or use). Such an abbreviated licensure pathway would enhance biological product competition and innovation and enable more streamlined and efficient development programs while maintaining robust safety, purity, and potency standards.

This legislative proposal is another one of those “Ohhhh. . . .  This is a nice idea.”  It would, as stated above, create an “abbreviated licensure pathway. . . conceptually similar to the pathway for follow-on drug products in section 505(b)(2) of the [FDC Act], which expressly allows an applicant to rely for approval on investigations that were not conducted by or for the applicant (and for which the applicant has not obtained a right of reference or use),” and allow for “enhance[d] biological product competition and innovation.”  It is also an idea we’ve seen bandied about for a few years, as we noted in a May 2022 post.

Explicitly Address Generic Drug-Device Combination Products

This proposal would amend section 505(j) of the FD&C Act to explicitly address the submission and review of drug-device combination products submitted in abbreviated new drug applications (ANDAs), as well as drug products submitted in an ANDA that are used with a device. Currently, section 505(j) of the FD&C Act does not explicitly address ANDAs for drug-device combination products and generic drugs used with a device, and also states that FDA cannot require ANDAs to contain information beyond that set forth in this section. The lack of clarity in certain statutory provisions in this section – which was established nearly 40 years ago at a time when most products were simpler – may, in certain circumstances, make it difficult for companies to develop generic versions of these products and for FDA to efficiently approve ANDAs for these products. As a result, these products, which are often complex products such as autoinjectors and inhalers, can see delayed generic market entry. FDA seeks amendments to clarify, among other things, that FDA can request and review data for such applications, that certain differences between the device constituent parts of the reference listed drug (RLD) and the proposed generic are permissible, and that differences in labeling between the RLD and the proposed generic as a result of permissible differences in the device are also permissible. This proposal would help promote generic competition and reduce the time, uncertainty, and cost of drug development for combination products.

This legislative proposal is a repeat from prior years.  More than 40 years ago, the Hatch-Waxman Amendments created the conventional ANDA pathway to approval for generic drugs.  At that time in the early 1980s, most products were in simpler dosage forms (e.g., tablet and capsule).  Today, products are increasingly in much more complex and sophisticated forms, including drug-device combination products like auto-injectors and next-generation inhalers.

Drug-device combination products are difficult for generic drug manufacturers to develop and for FDA to efficiently approve ANDAs within the current statutory framework for generic drugs because the statute does not explicitly reference the data and information that FDA may consider in assessing these products.  Without explicit authority addressing drug-device combination products, it has been challenging for industry to know which types of data and information applicants can use to develop a generic version of a brand-name drug that utilizes these new technologies, and FDA historically has required significant more time to review and act on ANDAs for these products compared to drug products in conventional forms.  This has resulted in delayed patient access to more affordable versions of these important products.

Accordingly, this legislative proposal would amend the Hatch-Waxman Amendments to accommodate recent—and to anticipate future—advances in therapeutic product evolution and emerging technologies.  In particular, FDA would get explicit authority to assess data and information for generic drug-device combination products, including those combination products that feature a device with differences from the brand-name product.

Clarify When Patent Information Must Be Submitted for a 30-Month Stay to Be Available

This proposal would amend provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to clarify that a 30-month stay of approval of an abbreviated new drug application (ANDA), 505(b)(2) new drug application (NDA), or abbreviated new animal drug application (ANADA) is available only in connection with patents that are submitted by the holder of the brand drug application under section 505(c)(2) or 512(c)(3) of the FD&C Act before the ANDA, 505(b)(2) application, or ANADA is submitted. If a patent is submitted for listing in the Orange Book by the NDA holder before an ANDA or 505(b)(2) application is submitted and, in response to notice of a paragraph IV certification, the NDA holder or patent owner initiates a patent infringement action against the ANDA or 505(b)(2) applicant within 45 days of receiving the required notice, approval of the ANDA or 505(b)(2) application generally will be stayed for 30 months from the later of the date of receipt of the notice by any owner of the patent or the NDA holder or such shorter or longer time as the court might order. However, if a patent is submitted for listing in the Orange Book after an ANDA or 505(b)(2) application is submitted but before it is approved, the applicant for the pending ANDA or 505(b)(2) application generally must amend its application and provide an appropriate patent certification or statement to the newly listed patent, but no 30month stay will be available in this circumstance. 

Current law is ambiguous with respect to whether patent information submitted as part of the NDA or New Animal Drug Application (NADA) before approval of the brand drug product can give rise to a 30-month stay of approval for an ANDA, 505(b)(2) application, or ANADA submitted after approval of the brand drug product and that relies upon the brand drug product if the ANDA, 505(b)(2) application, or ANADA is submitted before the NDA or NADA holder for the brand drug product has submitted patent information after approval for listing in the Orange Book (for NDAs) or Green Book (for NADAs). This proposal would address that ambiguity.

Though the language above is a bit unclear, this legislative proposal could be intended to address an issue that was raised in litigation against FDA in early 2024 concerning a 505(b)(2) NDA new strength supplement for Epinephrine Injection, 30 mg/30 mL (1 mg/mL), and that could be raised again in other Hatch-Waxman litigation.  In that case, which the D.C. District Court ruled on on May 2024, FDA issued a Letter Decision explaining the following in footnote 5:

The Agency has identified examples in which FDA has recognized a 30-month stay for new strength supplements for abbreviated new drug applications (ANDAs) based on an infringement action brought for patents listed after the date the original ANDA was submitted. To the Agency’s knowledge, the 30-month stays for these new strength supplements for ANDAs have either expired or have otherwise been terminated by a court and thus are moot. In these examples, the Agency appears to have recognized a 30-month stay because a new strength supplement is referencing a new listed drug with separately listed patent(s) in the Orange Book. However, the Agency looked more closely at these issues in the context of NDA 205029/S-013 and reevaluated the statutory language at section 505(j)(5)(B)(iii) of the FD&C Act. Section 505(j)(5)(B)(iii) of the FD&C Act does not exclude new strength supplements from the provision that limits the availability of a 30-month stay to patents for which the NDA holder submitted information to FDA “before the date on which the application (excluding an amendment or supplement to the application) . . . was submitted” and largely mirrors the language at section 505(c)(3)(C) of the FD&C Act. As a result of this reevaluation, FDA intends to change its practice with respect to new strength supplements for ANDAs and bring it into conformity with the statutory text. Going forward, the result will be that a 30-month stay will not be available for new strength supplements for ANDAs for patents submitted after the original ANDA was submitted (even where those patents were submitted before the submission of the new strength supplement). Because it is not directly implicated by this decision, FDA has not yet completed its assessment of new strength amendments that may be implicated by this issue. If FDA identifies any example in which FDA erroneously determined that there is an active 30-month stay either in the context of a new strength supplement or new strength amendment, it will review its decision to ensure that it conforms with the statutory text.

The legislative proposal could also be intended to address the situation where a generic drug manufacturer submits an ANDA after NDA approval (and before the 30-day patent information listing period has expired) with a Paragraph I certification and then amends the ANDA with a Paragraph IV certification, raising the argument that no 30-month stay on ANDA approval applies because the Paragraph IV certification was made in an amendment to the ANDA.

. . . . And we will add in one honorable mention . . . .

Align the FD&C Act with Longstanding Timelines and Procedures Governing Application Reviews and Streamline Appeals When an application is Not Approvable

FDA proposes to amend the FD&C Act to codify longstanding timelines and procedures that are central to FDA’s review of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, FDA proposes to amend subsections 505(c) and (j) of the FD&C Act (21 U.S.C. 355(c) and (j)) to remove the 180-day timeframe to either approve the application or give the applicant notice of an opportunity for a hearing (NOOH) on whether the application is approvable. FDA proposes to reference the goals identified in commitment letters under the Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA). FDA also proposes to amend section 505(c) and (j) of the FD&C Act to expressly include (1) the filing and receipt determinations described in FDA’s regulations and (2) FDA’s longstanding complete response letter (CRL) procedures. FDA further proposes to enhance efficiency by replacing the hearing-related processes described in section 505(c) and (j) of the FD&C Act with an appeal process modeled after the expedited withdrawal procedures for accelerated approval described in section 506(c)(3)(B) of the FD&C Act. 

Let’s call this legislative proposal the “Anti-Vanda Proposal,” as it appears to be an effort to legislatively address some of the litigations filed by Vanda Pharmaceuticals, Inc.  As we previously posted, Vanda has been anything-but-shy about suing FDA about anything and everything.  This includes Vanda’s February 2024 Complaint effectively challenging FDA’s PDUFA performance goals given the 180-day statutory review clock for marketing applications.

On April 22 and 23, 2026, the Association of Medical Diagnostic Manufacturers will hold its Annual Meeting at the Canopy by Hilton in Bethesda, MD.  The day and a half meeting, which is preceded by the group’s annual IVD 510(k) conference will be kicked off by Dr. Courtney Lias who will give the opening address providing the agency’s in vitro diagnostic regulatory update and overview.  Heads of the other OHT7 offices will also participate in a Q&A session.  Other highlights include a mock deposition, which will be conducted by HPMers Allyson Mullen and Jeff Gibbs with former FDA Special Agent in Charge, George Scavdis.  The case study will be sure to entertain the audience and underscore the key role FDA regulatory compliance – and internal documentation – can play in civil litigation.

The full agenda can be found on AMDM’s website (here).  FDA Law Blog readers can receive a 10% discount off the conference registration price.  To receive the discount, enter the code HPMBLOG at registration.  To register, visit the AMDM website.