Former FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional congressional authorities to fully implement its ...
Federal Register notice: FDA determines that Pfizers Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectivenes...
Federal Register notice: FDA makes available a draft guidance entitled Benefit-risk Considerations for Product Quality Assessments.
The International Medical Device Regulators Forum (IMDRF), of which FDA is a member, seeks comments on a proposed guidance entitled Principles and Pra...
CBER director Peter Marks tells a House briefing that FDA is not delaying its review of Modernas Covid-19 vaccine for children under five years old so...
FDA lifts a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia...
FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distributed Covid-19 test...
FDA posts a draft guidance entitled Benefit-Risk Considerations for Product Quality Assessments, which describes the agencys benefit-risk principles u...