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Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmatio...[ Price : $8.95]
FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally de...[ Price : $8.95]
Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components...[ Price : $8.95]
FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.[ Price : $8.95]
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and child...[ Price : $8.95]
Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices ...