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Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… On Monday, the Science Board to the FDA will convene to receive an update from the New Alternative Methods subcommittee and hear details about our reorganization, implemented on

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… We issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… This week, we continued ongoing efforts to increase access and supply of IV and peritoneal dialysis fluids following Hurricane Helene-related damage to Baxter International

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we responded to objections on the agency’s final rule that removed the authorized food contact uses of most phthalates because industry abandoned these uses.

🎧 Just joined @UnbiasedSciPod to dive into what drives us at FDA! We covered everything from the drug approval process & our commitment to safety & transparency, to advancing health equity & earning public trust. Tune in to get a closer look at our work! unbiasedscipod.com/episodes/the-a…

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Next week, the World Health Organization’s Member State Mechanism on Substandard and Falsified Medical Products will hold its 13th meeting in Geneva, Switzerland. Ahead of the

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we issued a request for information on per- and polyfluoroalkyl substances (PFAS) in seafood, seeking data and information from the seafood industry, academia, state and

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Yesterday, we published the FDA Voices: Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice. fda.gov/news-events/fd…

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Yesterday, we issued this guidance: Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices which provides a transitional

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we posted the final guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Thursday, we published the draft guidance, “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics,” which proposes updates to certain agency

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we announced that, on Jan. 1, 2025, the FDA will open the Voluntary Qualified Importer Program application portal for fiscal year 2026. fda.gov/food/hfp-const… Yesterday,

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Yesterday, FDA Drug Information announced the new CDER Center for Real-World Evidence Innovation, which aims to coordinate, advance, and promote the use of real-world data and