Federal Register notice: FDA submits to OMB an information collection extension entitled Medical Device User Fee Small Business Qualification and Cert...
Federal Register notice: FDA seeks comments on an information collection extension for its Agreement for Shipment of Devices for Sterilization 21 CFR...
FDA approves CSL Behrings four- and five-gram vial sizes for Zemaira [alpha1-proteinase inhibitor (human)], its therapy for treating Alpha 1 Antitryps...
Federal Register notice: FDA makes available a final guidance on Unique Device Identification: Convenience Kits.
FDA announces a joint meeting of two advisory committees to discuss safety concerns that have been raised about safe prescribing and use of higher-ran...
FDA approves a Xvivo Perfusion PMA for the Xvivo Perfusion System with Steen Solution Perfusate, indicated to temporarily ventilate, oxygenate, and pu...
FDA approves the use of GlaxoSmithKlines Benlysta (belimumab) intravenous, a B-lymphocyte stimulator-specific inhibitor, in children aged five years a...
Former FDA commissioner Robert Califf says the best long-term way to control drug prices is through value-based pricing.