The question of whether hydroponic operations are eligible for organic certification in the United States has been debated since 1995. In most countries, such as Mexico and Canada, and regions, such as the EU, organic certification cannot be extended to crops not grown in soil. …
Next Thursday, February 7, the Food and Drug Law Institute will conduct a webinar entitled, “Patient Assistance Programs, Recent Enforcement and Best Practices.” The webinar will cover the various forms of patient assistance programs, the legal authorities that apply to them, recent enforcement actions, best …
In one of the multiple lawsuits that Pharmaceutical Manufacturing Research Services (PMRS) has filed against the FDA related to the approval of abuse-deterrent opioids in the last few years, the Eastern District of Pennsylvania summarily rejected PMRS’s bid to keep abuse-deterrent opioid, RoxyBond, off the …
On January 7, 2019, FDA released new documents related to its Software Pre-Certification (Pre-Cert) Program: Developing a Software Precertification Program: A Working Model (Working Model) Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities (Regulatory Framework) Software Precertification Program: 2019 Test Plan (Test Plan) In …
On December 17, 2018, FDA published a final rule, Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures, to amend its regulations governing classification and reclassification of medical devices to align with the relevant portions of the Federal Food, Drug, …
Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price. Under Section 340B of the Public Health Service Act, a manufacturer of covered outpatient drugs, as a condition of having its drugs be eligible for federal …
CBI is holding its Fourth Edition Drug Pricing Transparency Congress on March 25-26, 2019 in Philadelphia, Pennsylvania. This program convenes stakeholders to discuss how the future of drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices. Given the novelty and complexity of …
Enforcement discretion for stem cell facilities (and certain other HCT/P manufacturers) ends in November of 2020, and as FDA indicated in a recent press release, the agency is “discouraged” by the dearth of manufacturers wanting to interact with them during the enforcement discretion period. Back in …
Though FDA does not have the legal authority to control or even directly address drug prices, Commissioner Gottlieb has certainly not shied away from the issue. In fact, drug (and biologic) competition and accessibility is one of Dr. Gottlieb’s main efforts at the Agency (see …
On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced updates to its “Code of Ethics on Interactions with Health Care Professionals” (Code). The Code was last updated in 2008; the newest updates will become effective on January 1, 2020. The Code includes new sections …
In November of 2017, FDA published its enforcement discretion policy regarding HCT/Ps that don’t meet all four criteria under 21 CFR 1271.10(a): To give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance and, if such …
As we previously reported, Vermont Governor Phil Scott signed a new law in May 2018 allowing for the wholesale importation of prescription drugs from Canada into Vermont. Vermont’s Agency of Human Services (VAHS) recently issued a report containing the Agency’s preliminary design for a “Canadian …
In the midst of the government shutdown and with its accompanying lull in new FDA documents, we thought it would be a good time to update our readers on some guidances that were issued late last year. Two such notable draft guidances were the, “Select …
On December 18, 2018, FDA opened a docket for public comment regarding its intention to shorten the grace period for Global Unique Device Identification Database (GUDID) submissions from thirty days to seven days. The grace period starts when Device Identified (DI) information is first entered …
In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week. In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution …
