CDER Office of Clinical Pharmacology researchers outline the value of leveraging clinical pharmacology principles during drug development and evaluati...
Rep. A Donald McEachin introduces legislation to allow generic drug manufacturers to independently add safety-related information to product labels.
FDA researchers say the use of pediatric extrapolation since 2015 has expanded and been refined.
House and Senate negotiators agree to terms to reauthorize the agencys user fee programs under a clean absent any policy/program riders measure that...
FDA sends a Warning Letter to German over-the-counter drug manufacturer System Kosmetik Produktionsgesellschaft fur kosmetische after inspecting the f...
Federal Register proposed rules: FDA issues two proposed rules that modify certain research requirements regarding approval/oversight by institutional...
Biogen pays $900 million to resolve allegations that it violated the False Claims Act by causing the submission of false claims to Medicare and Medica...
Stakeholders make recommendations they say would improve an FDA draft guidance on remote regulatory assessments.
