Three former FDA Team Biologics inspectors tell Politico inspections are being conducted by team members who do not have sufficient experience or trai...
Former FDA commissioners Scott Gottlieb and Mark McClellan call on Congress to promptly pass the VALID Act to modernize FDA regulation of laboratory-d...
FDA posts a final guidance on pharmacokinetic-based criteria used to supporting alternative dosing programmed cell death receptor-1 or programmed cell...
Federal Register notice: FDA makes available a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-A...
Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issues associated with t...
FDA updates a January safety communication about the use of Endologix AFX endovascular grafts for treating patients with abdominal aortic aneurysms.
FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was placed 11/4 on VERVE-101...
FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approved in 2017.
