FDA associate commissioner for regulatory affairs Judy McMeekin updates the Food and Drug Law Institute on inspectional activity overseen by the new F...
FDA gets a $9.2 million HHS grant to expand CURE ID for automated data collection from electronic health records and clinical disease registries.
Federal Register notice: FDA makes available a draft guidance entitled Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.
Iovance Biotherapeutics says FDA regulatory feedback on potency assays for lifileucel will delay a planned BLA for the therapy.
International business management consultancy Sedgwick says drug and medical device product recalls are likely to surge as companies return to busines...
The Pew Trusts calls for legislative action to maintain FDA authority over laboratory-developed tests.
Federal Register notice: FDA determines that Adams Technologies Isoptin (verapamil hydrochloride) tablets (40mg, 80mg and 120mg) and Pfizers Calan (ve...
FDA acting commissioner Janet Woodcock suggests changes to the nations clinical trial system in response to pandemic lessons learned.