The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2022 (PDUFA VII), authorizes FDA to […]

On This Page Date: September 17, 2025 Time: 9:30 a.m. – 2:30 p.m. ET The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the […]

Action The U.S. Food and Drug Administration (FDA) approved Wayrilz (rilzabrutinib) tablets to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-104 Product: Drugs Recipient: Recipient Name Mr. Chintu Patel Recipient Title Co-Chief Executive Officer Amneal Pharmaceuticals, LLC 50 Horseblock […]

Delivery Method: Via Email Reference #: 320-25-101 Product: Animal & VeterinaryDrugs Recipient: Recipient Name Mr. Ronald E. Sutton Recipient Title President & Owner Chromatography Institute of […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Martin Pytela Recipient Title President Life Enthusiast Co-op 711 S Carson Street Suite 4Carson City, NV 89701United […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-103 Product: Drugs Recipient: Recipient Name Mr. Heath Ashenfelter Recipient Title President and CEO Wisconsin Pharmacal Company, […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Josue Carias Recipient Title CEO Mel Honey US 152 Wapiti LoopHyrum, UT 84319-2012United States [email protected] Issuing Office: […]