The Government Accountability Office says FDA may be challenged in resuming routine surveillance inspections of vaccine and allergenic manufacturing f...
FDA contracts with the Yale School of Medicine to promote clinical trial awareness and access to underrepresented minorities.
FDA says it has taken three new actions to strengthen the risk communication about breast implants and help consumers to make informed decisions.
Federal Register notice: FDA announces an 11/30 Antimicrobial Drugs Advisory Committee meeting to review a Merck Emergency Use Authorization request f...
Federal Register notice: FDA announces the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal...
FDA is joining with 16 other organizations to increase effective gene therapies for rare diseases.
CDER Office of Compliance director Don Ashley tells the Pharmaceutical Quality Symposium that during the Covid-10 pandemic, more than 70 bioresearch m...
FDA publishes two lists of final and draft guidance topics for FY 2022 and a list of final guidances from four years for comment on whether they shoul...