FDA Related News

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FDA says it will receive comments until 2/28 on a draft guidance on the possibility for cancer drug sponsors and FDA to prepare a joint briefing docum...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

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.

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.

Human Drugs

NEWSROOM CLOSED FOR THE HOLIDAYS

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

Medical Devices

Zimmer Biomet Stemless Shoulder System

FDA clears a Zimmer Biomet 510(k) for the OsseoFit Stemless Shoulder System for total shoulder replacement.

Human Drugs

CDER Right-to-Try Summaries Can Go Thru Portal

CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.

Human Drugs

Guide on Tech Specs for NASH Drug Data Sets

FDA posts a final guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steato...