The Washington, DC District Court rules that a recent FDA decision to remove a decades-old compliance policy affecting unapproved homeopathic drugs ca...
FDA warns KVK-Tech about CGMP violations in its production of finished drugs.
Federal Register notice: FDA announces a 12/8-9 virtual public meeting entitled The Drug Supply Chain Security Act Pilot Project Program and Enhanced ...
Federal Register notice: FDA announces a 12/16 advisory committee meeting to discuss spironolactone for the proposed treatment of heart failure with p...
Federal Register notice: FDA announces a 12/15 advisory committee meeting that will review a Novartis supplemental NDA for Entresto (sacubitril and va...
FDA awards a multi-year grant to C-Path to advance standards and methodologies designed to generate real-world evidence from real-world drug data in a...
FDA releases its latest batch of Warning Letters that include KVK-Tech and Shilpa Medicare Limited.
FDA grants Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System.