FDA Review posts the Federal Register notices for the week ending 10/15/2021.
FDA Review posts product approval summaries for the week ending 10/15/2021.
Former FDA associate commissioner Peter Pitts says FDA needs a deputy commissioner for regulatory competitiveness to aggressively develop, coordinate,...
FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have ...
FDA approves Genentechs Tecentriq (atezolizumab) as an add-on treatment following surgery and platinum-based chemotherapy for adults with Stage II-III...
Two Hyman, Phelps & McNamara attorneys take issue with FDAs new approach to regulate novel robot assisted surgery devices for specific indications rat...
Lupin recalls all irbesartan and irbesartan/hydrochlorothiazide tablets after finding some active pharmaceutical ingredient batches were above the spe...