Here is a concise overview of recent FDA developments:
The FDA will not publish the FDA Roundup during the week of Dec. 25 and plans to resume on Jan. 2, 2024. The agency encourages everyone to take precautions against fall respiratory illnesses, follow food safety tips for healthy holidays, and safeguard pets during festive preparations. Warm wishes for a joyful holiday season from the FDA.
Today, the FDA released industry guidance titled "Rare Diseases: Considerations for the Development of Drugs and Biological Products." This guidance aims to provide valuable insights into rare disease drug development, assisting developers in navigating successful drug development programs. For additional information and to submit comments, please visit Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry; Request for Comments.
On Thursday, the FDA cautioned consumers against using counterfeit Ozempic (semaglutide) discovered in the U.S. drug supply chain. The agency is actively investigating counterfeit Ozempic injection 1 milligram (mg) within the legitimate U.S. drug supply chain and has seized thousands of units. Wholesalers, retail pharmacies, healthcare practitioners, and patients are urged to verify their products, specifically those labeled with lot number NAR0074 and serial number 430834149057, and refrain from distribution, use, or sale.
Also on Thursday, the FDA published "Catching Up with Califf: Realizing the Promise of Real-World Evidence" by Robert M. Califf, M.D., Commissioner of Food and Drugs. This installment discusses the growing interest in using real-world evidence (RWE) for regulatory decision-making, addressing challenges and ongoing efforts at the FDA to understand and advance this area. The FDA has issued a series of guidances on RWE, including three published this week.
Additionally, on Thursday, the FDA's Center for Veterinary Medicine unveiled the final Guidance for Industry #61, "Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species," to enhance the availability of safe and effective new animal drugs for minor uses and minor species.
On Wednesday, the FDA published "Catching Up with Califf: Increasing Options in Clinical Research to Facilitate Medical Product Development." In this piece, Commissioner Califf discusses efforts to harmonize clinical research regulations and facilitate the development of medical products while safeguarding participant rights and safety.
Also on Wednesday, the FDA issued the final guidance, "Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization," providing updated recommendations reflecting the evolving scientific knowledge and the current state of COVID-19.
Furthermore, on Wednesday, warning letters were issued to three online retailers for selling unauthorized e-cigarettes imitating alcohol packaging. Luckee Vape Daniels brands, flavored disposable e-cigarette products, were sold in enticing alcoholic drink flavors. The FDA emphasizes the prevalence of disposable products among U.S. middle and high school students and addresses concerns about flavored e-cigarette use.
Finally, on Wednesday, the FDA issued the draft guidance, "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review," outlining updates to the 510(k) Third Party Review program and detailing how the FDA may rely on third parties to review EUA requests to rapidly expand resources during emergencies.
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