FDA issues a draft guidance on 510(k) submissions for metal expandable biliary stents.
FDA extends by three months the review of a Janssen Pharmaceutical Companies supplemental NDA for Invokana (canagliflozin), indicated for reducing the...
FDA approves a Stryker PMA for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms.
FDA says several companies have recalled their valsartan-containing drug products, which are used to treat high blood pressure and heart failure, due ...
FDA clears a Quidel Corp. 510(k) for the Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecular diagnosti...
Federal Register notice: FDA files for OMB clearance an information collection extension for New Animal Drugs for Investigational Use.
Federal Register notice: FDA makes available a draft guidance entitled Hypertension: Conducting Studies of Drugs Treat Patients on a Background of Mul...
Federal Register notice: FDA files for OMB clearance an information collection extension for Petition To Request an Exemption From 100% Identity Testi...