FDA commissioner Marty Makary discusses upcoming actions to encourage more prescription-to-over-the-counter drug switches.
Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Time Oncology Review pr...
FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four months in operation.
Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information, warning that the cu...
Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compounded forms of its sema...
FDA asks Capricor Therapeutics for a full clinical study report from the companys Phase 3 HOPE-3 trial as part of its ongoing BLA review for Deramioce...
FDA publishes for review and comment the International Council for Harmonization M4Q(R2) guidance establishing the location and structure of quality i...
FDA warns Integrity Partners St. Louis, MO-based Chemisphere drug manufacturing facility about CGMP issues in its production of finished drugs as a co...
