A House Energy and Commerce Committee legislative package to reauthorize FDA user fee agreements aims to address agency predicaments caused by recent ...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studie...
FDA clears a VideaHealth 510(k) for its Videa Caries Assist, an artificial intelligence-powered dental caries (cavity) detection algorithm.
FDA limits the emergency use authorization of Janssens Covid-19 vaccine to certain individuals 18 years of age and older due to the risk of thrombosis...
Attorney Bradley Thompson uses data analysis to determine medical device inspection observations that more frequently are associated with Warning Lett...
Federal Register notice: FDA announces its renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond...
Federal Register notice: FDA makes available a draft guidance entitled Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.
Harvard University researchers who looked at FDAs use of advisory committees for new drugs say reforms in the process would improve transparency and a...