[ Price : $8.95]
Rep. A Donald McEachin introduces legislation to allow generic drug manufacturers to independently add safety-related information ...[ Price : $8.95]
FDA researchers say the use of pediatric extrapolation since 2015 has expanded and been refined.[ Price : $8.95]
House and Senate negotiators agree to terms to reauthorize the agencys user fee programs under a clean absent any policy/program ...[ Price : $8.95]
FDA sends a Warning Letter to German over-the-counter drug manufacturer System Kosmetik Produktionsgesellschaft fur kosmetische af...[ Price : $8.95]
Federal Register proposed rules: FDA issues two proposed rules that modify certain research requirements regarding approval/oversi...[ Price : $8.95]
Biogen pays $900 million to resolve allegations that it violated the False Claims Act by causing the submission of false claims to...[ Price : $8.95]
Stakeholders make recommendations they say would improve an FDA draft guidance on remote regulatory assessments.[ Price : $8.95]
Five stakeholders raise substantive concerns about an FDA draft guidance on selecting, developing, or modifying fit-for-purpose cl...