FDA issues ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection documented GMP violations.
Rep. Gregory Murphy asks FDA for its views on several aspects of using artificial intelligence in medical care as a prelude to regulatory legislation.
ROi CPS of Republic, MO, recalls its Regard Wound Dressing change kit due to it containing nonconforming material/component.
Federal Register notice: FDA makes available a draft document entitled Food and Drug Administrations Draft Report and Plan on Best Practices for Guida...
FDA says it is evaluating the need for regulatory action after seeing a safety signal for some additional side effects in GLP-1 receptor agonists like...
FDA clears a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner.
FDA removes a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous and peripheral T-cel...
PhRMA says FDA should consolidate its recent draft guidance on Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bioresearch Monitoring F...
