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Federal Register Notice: FDA makes available a final guidance on how to reference Approved drug products in ANDA submissions.[ Price : $8.95]
FDA releases a meeting summary with recommendations on artificial intelligence and machine learning from the Patient Engagement Ad...[ Price : $8.95]
CDER publishes a MAPP on responsibilities and procedures for developing two types of REMS.[ Price : $8.95]
FDA posts a revised guidance on its enforcement policy for Remote Monitoring Devices Used During Covid-19 Emergency.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance conducting tobacco product perception and intention studies.[ Price : $8.95]
FDAs Circulatory System Devices Advisory Panel votes 13 to 3 against recommending PMA approval for Neovascs Reducer for treating c...[ Price : $8.95]
FDA warns KVK-Tech about CGMP violations in its production of finished drugs.[ Price : $8.95]
Federal Register notice: FDA announces a 12/8-9 virtual public meeting entitled The Drug Supply Chain Security Act Pilot Project P...