The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.
Similar Posts
FDA In Brief: FDA issues draft guidance to foster oncology product development for pediatric populations
FDA issues draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.” The draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs.Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.Force Forever may be harmful due to hidden drug ingredients
Consumers should not to purchase or use Force Forever, a product promoted and sold for joint painOlympus Announces Voluntary Corrective Action for the Single-Use Ligating Device
Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device (“Polyloop”) following identification of a potential safety issue.Genzyme Ireland Limited – 01/17/2025
Genzyme Ireland Limited – 01/17/2025. Country: Ireland. Record Type: 483Creative Essences, Inc. – 710658 – 09/25/2025
CGMP/Finished Pharmaceuticals/Adulterated
