FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally derived measures in cl...
Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components.
Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.
Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices based on patient-cen...
FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) in adults with fibrod...
FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, including personalized ca...
FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.
