FDA warns Seattle, WA-based Kari Gran, Inc., about CGMP violations and data integrity issues in its production of finished drugs.
As a sign FDA is continuing to raise the bar on data needed to gain approval for a PI3K inhibitor, MEI Pharma and Kyowa Kirin decide to abandon develo...
CDER researchers describe Covid-19 drug safety surveillance lessons learned.
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...
