Outsourcing Facility Inspections Compliance Program 1/15/2025 Outsourcing Facility Inspections Considerations for Complying with 21 CFR 211.110 Guidance 1/6/2025 Drug Product, CGMP, Emerging/Advanced Tech MAPP 5018.3 Implementation […]

For Immediate Release: September 03, 2025 The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability […]

Summary FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) propose a new process under Rare Disease Evidence Principles […]

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 […]

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 […]

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 […]