CBER increases from 13 to 17 the number of guidances it expects to develop in 2022.
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Federal Register notice: FDA determines that Pfizers Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectivenes...
Federal Register notice: FDA makes available a draft guidance entitled Benefit-risk Considerations for Product Quality Assessments.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...