Four drug companies recommend technical changes to an FDA draft guidance on evaluating cancer drugs in patients with central nervous system metastases...
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Federal Register notice: FDA makes available a draft guidance conducting tobacco product perception and intention studies.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...