Two stakeholders make suggestions for changes to an FDA draft guidance on investigator responsibility for safety reporting for investigational drugs a...
FDAs Antimicrobial Drugs Advisory Committee narrowly votes 13-10 to recommend an emergency use authorization for Mercks oral antiviral molnupiravir fo...
Teleflex recalls its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device Kit, 7FR, after receiving reports about the inner lumen becoming d...
FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mut...
Three Hyman, Phelps attorneys say an HHS announcement withdrawing a Trump administration policy on FDA review of laboratory-developed tests leaves man...
FDA sends Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for preventing ototoxicity...
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committ...
Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug ...