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Federal Register notice: FDA makes available a draft guidance conducting tobacco product perception and intention studies.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 KVK-Tech about CGMP violations in its production of finished drugs.
Federal Register notice: FDA announces a 12/8-9 virtual public meeting entitled The Drug Supply Chain Security Act Pilot Project Program and Enhanced ...