FDA approves a Rudy Giuliani-touted Celularity IND for its investigational stem cell therapy in Covid-19 patients.
FDA releases the FDA-483 with three observations issued following an inspection at Malaysias Biocon Sdn Bhd.
FDA warns dietary supplement manufacturer Bulletproof 360 about CGMP and new and misbranded drug violations.
FDA warns Steiner Biotechnology about violations in its conduct of nonclinical laboratory studies.
FDA proposes to reclassify two types of hepatitis C diagnostic tests from Class 3 to Class 2 with special controls.
Federal Register notice: FDA amends certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k))...
FDA asks manufacturers of all Rx and OTC ranitidine products to remove them from the market due to NDMA contamination.
Federal Register notice: FDA amends its medical device regulations to reflect changes to CDRHs organizational structure, including the reorganization ...