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Federal Register notice: FDA makes available a draft guidance conducting tobacco product perception and intention studies.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.
FDA issues a guidance on how ANDA applicants should accurately refer to a reference-listed drug, reference standard, and the basis of submission.
FDA says it is delaying until 2/3/2022 enforcement of compliance with PMA requirements for AED accessories.
NIH ends enrollment in a clinical trial of a Lilly investigational monoclonal antibody intended to treat hospitalized Covid-19 patients.