Federal Register notice: FDA announces a 12/7-8 virtual public meeting entitled Drug Supply Chain Security Act Implementation and Readiness Efforts fo...
Washington Legal Foundation says the DC Circuit federal court should grant summary judgment in favor of a Vanda Pharmaceuticals suit seeking to compel...
FDA clears a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage triage and notification product.
An FDA advisory committee votes 8 to 5 to recommend against an emergency use authorization for Verus investigational prostate cancer drug VERU-111 (sa...
FDA warns Carrollton, TX-based NatureLab about adulterated and mislabeled dietary supplements.
FDA warns Phoenix, AZ-based Abraxis Bioscience about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA publishes a draft guidance with recommendations on how ANDA applicants can demonstrate sameness between the active ingredient in the proposed gene...
FDA raises uncertainties with Verus request for Covid-19 treatment emergency use authorization for its repurposed investigational cancer drug sabizabu...
