FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.
Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.
Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2025.
FDA warns Brooklyn, NY-based Amco International Manufacturing & Design about illegally manufacturing and distributing adulterated automated external d...
The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic approvals in 2023.
FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pa...
Federal Register notice: FDA releases fiscal year 2025 rates for generic drug user fees.
