The Senate Appropriations Committee marks up and approves FDAs fiscal year (FY) 2025 budget, providing a $170 million (2.5%) boost over the FY 2024 sp...
FDA publishes draft guidances with recommendations on 510(k) submissions for dental composite resins and curing lights.
FDA publishes a guidance recommending principles for use in pivotal clinical studies to demonstrate the safety and effectiveness of medical devices tr...
Kazia Therapeutics says it will meet with FDA about a potential accelerated approval pathway for its glioblastoma drug paxalisib following positive ov...
Federal Register notice: FDA announces an 8/6 public workshop entitled Artificial Intelligence (AI) in Drug & Biological Product Development.
Federal Register: FDA schedules an 8/2 advisory committee meeting to discuss a Zevra Denmark A/S NDA for arimoclomol, indicated for treating Niemann-P...
FDA clears ImmersiveTouchs ImmersiveAR virtual and augmented reality operating room platform.
CBER issues a standard operating policy and procedure staff guide on administrative processing and review management procedures for INDs received by t...
