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Federal Register notice: FDA makes available a draft guidance entitled Annual Reportable Labeling Changes for NDAs and ANDAs for N...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Premarket Cybersecurity Guidance: Se...[ Price : $8.95]
Federal Register notice: FDA renews its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two ...[ Price : $8.95]
A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA should help industry learn how to avoid labs that...[ Price : $8.95]
FDA warns Gainesville, FL-based Exactech about Quality System and Medical Device Report violations in its manufacturing of orthope...[ Price : $8.95]
FDA publishes a draft guidance with recommendations for NDA and ANDA applicants for nonprescription drugs to document minor labeli...[ Price : $8.95]
CVM warns Boehringer Ingelheim Animal Health USA that promotional communications for its Senvelgo make false and misleading claims...[ Price : $8.95]
FDA publishes a draft guidance proposing select updates to its existing premarket cybersecurity guidance.