FDA Related News

Human Drugs

AMT Designation Program Guidance

FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Program.

Human Drugs

ICH E11A Pediatric Extrapolation Guidance

FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.

ICH Clinical Practice Guide Annex

FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.

Human Drugs

Brands International Limits, Delays Inspection: FDA

FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.

Medical Devices

Multiple Violations in BD Inspection

FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management System.

Clinical Investigation Protocol Deviations

FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.

Medical Devices

Updated POLARx Instructions is Class 1 Recall: FDA

FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.

Human Drugs

FDA Seeks Comments on ODAC Briefing Guidance

FDA says it will receive comments until 2/28 on a draft guidance on the possibility for cancer drug sponsors and FDA to prepare a joint briefing docum...

Human Drugs

CGMP Violations in Akorn Formulations Review

FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for the U.S. market.

Human Drugs

NEWSROOM CLOSED FOR THE HOLIDAYS

FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Thursday, Jan 2, 2025.