A new Government Accountability Office report says FDA needs better planning for its recruitment and retention of medical product staff.
Federal Register notice: FDA announces a 3/10 virtual public hearing on scientific data and information related to the residue of carcinogenic concern...
A physician and a trade association executive say FDA requirements for using Covid-19 antiviral drugs will work against people who could benefit from ...
FDA puts a clinical hold on Denali Therapeutics DNL919 IND for Alzheimers.
FDA releases nine safety summaries for materials that are commonly used in implantable medical devices.
GlaxoSmithKline and Vir ask FDA to allow intramuscular administration of their Covid-19 monoclonal antibody treatment sotrovimab.
The Justice Department says Miamis Olga Torres pleaded guilty to obstructing an FDA inspection at the Florida clinical research site she co-owned.
FDA has cleared a G-Tech Medical 510(k) for its Wireless Patch System for myoelectric activity measurement as an aid in diagnosing and treating gastro...