FDA issues a draft guidance on 510(k) submissions for metal expandable biliary stents.
Three stakeholders raise concerns and suggest improvements to an FDA proposed rule on product jurisdiction.
FDA releases its latest batch of Warning Letters that include Baxter (Claris Injectables Ltd.) and bB BioChem Laboratories.
FDA extends by three months the review of a Janssen Pharmaceutical Companies supplemental NDA for Invokana (canagliflozin), indicated for reducing the...
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Federal Register notice: FDA makes available a draft guidance entitled Hypertension: Conducting Studies of Drugs Treat Patients on a Background of Mul...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...