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FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage...[ Price : $8.95]
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.[ Price : $8.95]
Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.[ Price : $8.95]
Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.[ Price : $8.95]
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2025.[ Price : $8.95]
FDA warns Brooklyn, NY-based Amco International Manufacturing & Design about illegally manufacturing and distributing adulterated ...[ Price : $8.95]
The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic appro...[ Price : $8.95]
FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderat...