Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target Healths notificatio...
FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.
FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse Labs in Pune, India, d...
Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-interventional studies...
FDA lifts a partial clinical hold on PTC Therapeutics PTC518 for treating Huntingtons disease based on the agencys review of Phase 2 trial data (PIVOT...
FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.
Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.
Federal Register notice: FDA announces a 7/17 educational conference (public meeting) entitled First Annual Animal Drug User Fee Educational Conferenc...
