FDA posts a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process.
Federal Register notice: FDA submits for OMB approval a new proposed information collection entitled DSCSA Pilot Project Program.
Rep. Tulsi Gabbard (D-HI) and senator Bernie Sanders (I-VT) introduce legislation to hold pharmaceutical companies accountable for profiting from Amer...
FDA approves a subcutaneous formulation of Genentechs Actemra (tocilizumab) for treating active polyarticular juvenile idiopathic arthritis in patient...
Federal Register notice: FDA announces a partial withdrawal of a proposed rule published in the 8/21/2003 Federal Register that would have amended the...
FDA clears a Baxter International 510(k) for the Spectrum IQ Infusion System with Dose IQ Safety Software.
FDA approves a UCB supplemental NDA for Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in treating parti...
FDA grants Immunicom a breakthrough device designation for its Immunopheresis therapy, which is based on a proprietary technology that selectively rem...