FDA publishes a guidance describing its use of some alternative tools in specified drug facility inspections.
CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.
FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice of convening indepe...
Intercept Pharmaceuticals withdraws Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis, following an FDA request...
A USC Schaeffer Center for Health Policy and Economics white paper urges FDA to take several steps it says can modernize drug development.
The Securities and Exchange Commission agrees to accept a FibroGen payment of $1.25 million to resolve a case involving tampering with roxadustat clin...
A Clinical Trials Transformation Initiative meeting summary highlights four key issues discussed at its session on the state of clinical trials.
FDA schedules an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence in digital mental health med...
