FDA says it will receive comments until 2/28 on a draft guidance on the possibility for cancer drug sponsors and FDA to prepare a joint briefing docum...
FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for the U.S. market.
FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.
FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Program.
FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.
FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Thursday, Jan 2, 2025.
