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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]
Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices ...[ Price : $8.95]
FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) i...[ Price : $8.95]
FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, inclu...[ Price : $8.95]
FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.[ Price : $8.95]
Merck and Moderna say a Phase 3 trial of Keytruda and intismeran autogene met key endpoints as an adjuvant melanoma treatment.[ Price : $8.95]
FDA warns Indias Auriga Research contract testing laboratory about CGMP violations in its testing of drugs for clients.