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.

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...

Human Drugs

FDA Promotes Centralized Statistical Trial Monitoring

FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.

Human Drugs

McKinsey & Co. Pays $650 Million in Opioid Case

McKinsey & Co. agrees to pay $650 million to settle both criminal and civil investigations into its advisory work with Purdue Pharma and the marketing...