We have seen the stock language in every guidance document FDA issues claiming its guidance is non-binding: This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is …
On January 24, 2018, FDA and the Federal Trade Commission (FTC) posted joint warning letters to 11 marketers and distributors of opioid cessation products, alleging that those products were unapproved new drugs that violated the Federal Food, Drug, and Cosmetic Act (FDC Act) and made …
The final Unique Device Identifier (UDI) Rule was published on September 24, 2013. The last phases of implementation related primarily to Class I and Unclassified devices. Due to complex issues identified during implementation of the UDI Rule for Class II and III devices, FDA is …
FDA issued a draft guidance that addresses public warning and notification of recalls under the agency’s recall regulation at 21 CFR part 7, subpart C (see here and here). Although the draft guidance extends to recalls of nearly all FDA-regulated products, it is of particular importance …
The title of this blog post should tell you everything you need to know about the proposed appeal regulations announced last week by CDRH (found here). On January 17, CDRH proposed regulations specific to the device appeal process for both 517A decisions as well as …
The Department of Justice recently issued a memo to all attorneys in the Commercial Litigation Branch, Fraud Section, and any Assistant U.S. Attorneys handling False Claims Act (FCA) cases, directing those attorneys to seek dismissal of FCA cases under certain circumstances. While the government’s ability …
A week before Christmas, CDRH issued a revised draft of the Replacement Reagent policy. When finalized, the revised draft guidance will replace the 2003 final guidance. According to FDA, the revised guidance “is intended to update and provide clarity on” the existing policy. FDA has …
As stated in our blogpost discussing FDA’s announcement of 2018 Compounding Policy Priorities (here). FDA also released its Final Guidance on Compounding “essentially copies” of commercially available drugs. This long-anticipated guidance discusses how FDA intends to determine whether a compounded drug is essentially a copy …
In 2015, FDA proposed to revise the intended use regulations, which describe how the agency determines the intended use of a drug or device, including the types of evidence that may be considered. FDA’s proposed rule would have deleted the infamous “knowledge” sentence, which could …
Last week FDA announced the release of its 2018 “Compounding Priorities Plan.” FDA also released several guidance documents in the wake of its announcement, such as its final guidance on essentially copies of commercially available drug products for Section 503A and 503B facilities (more on …
On December 29th, the Drug Enforcement Administration (“DEA”) published notice of its intent to temporarily control fentanyl-related substances that are not currently regulated under the Controlled Substances Act (“CSA”). Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 82 Fed. Reg. 61700 …
As we previously reported, in October 2017, the New Jersey Attorney General and Division of Consumer Affairs issued a proposed rule in response to concerns about the amount of money being paid to prescribers in the state of New Jersey. On December 22, 2017, the …
On January 4, the Federal Trade Commission (FTC) announced the release of a new guidance by FTC staff concerning Multi-Level Marketing (MLM). The guidance, in the form of questions and answers, addresses issues relevant for businesses evaluating their compliance with the FTC Act. Multi-level marketing is …
On December 20, FDA issued a new, draft guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways.” This guidance is the latest chapter in the years-long, and still on-going, story of accessory classification. As you may recall, Congress and FDA have both been working …
In a thorough and thoughtful 23-page opinion, Judge Steven Merryday of the Middle District of Florida dismissed a $350 million judgment against the defendants, owners and operators of specialized nursing facilities. The court detailed the rigorous materiality and scienter requirements for liability under the False …
