FDA Related News

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

ICH M15 Model-Informed Drug Development Principles

FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.

Human Drugs

AMT Designation Program Guidance

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

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.

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...