On June 27 the Food and Drug Administration (FDA) published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, the FDA provides examples of activities prohibited
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between FDA’s Center for Drug
On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits regarding their arguments that the FDA
On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the FDA approval of the abortion drug mifepristone. The Texas decision blocks prescribing and dispensing of mifespristone nationwide, while the Washington
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. The nonbinding guidance, titled “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices
FDA inspections of biopharmaceutical manufacturers often lead to the discovery of avoidable compliance issues.
On today’s episode, Staying Ahead of the Curve in BioPharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions, we discuss tips
On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans
On March 6, the FDA announced the launch of its new “Dietary Supplement Ingredient Directory.” According to the FDA, the directory is “a one-stop shop of ingredient information that was previously found on different FDA webpages.” It will
FDA Commissioner Robert M. Califf, MD, MACC, released a statement on Feb. 24, 2023, announcing next steps the FDA’s CTP plans to take in response to an external evaluation conducted by the Reagan-Udall Foundation. Califf commissioned the external evaluation in
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm