Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.
FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally derived measures in cl...
FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and ...
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components.
Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices based on patient-cen...
