Federal Register notice: FDA makes available a final guidance entitled Necessary Automated External Defibrillator Accessories: Policy Regarding Compli...
Federal Register Notice: FDA makes available a final guidance on how to reference Approved drug products in ANDA submissions.
FDA releases a meeting summary with recommendations on artificial intelligence and machine learning from the Patient Engagement Advisory Committee.
CDER publishes a MAPP on responsibilities and procedures for developing two types of REMS.
FDA posts a revised guidance on its enforcement policy for Remote Monitoring Devices Used During Covid-19 Emergency.
Federal Register notice: FDA makes available a draft guidance conducting tobacco product perception and intention studies.
FDAs Circulatory System Devices Advisory Panel votes 13 to 3 against recommending PMA approval for Neovascs Reducer for treating certain patients with...
FDA warns Indias Shilpa Medicare Limited about CGMP and field alert reporting violations in its manufacturing of finished drugs.