Draeger recalls (Class 1) its ErgoStar CM 60 (catheter mount 60), an airway connector/catheter mount, after receiving multiple complaints reporting de...
CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription marketing status and AN...
CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on single-arm studies ...
Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially involving off-label presc...
FDA warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract manufacturer.
FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program, permitting new U.S...
A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval requirements.
FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.
