FDA Review posts product approval summaries for the week ending 4/26/2019.
Federal Register notice: FDA makes available a final guidance entitled Recommended Content and Format of Non-Clinical Bench Performance Testing Inform...
Federal Register notice: FDA makes available a final guidance entitled Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Or...
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...