FDA Related News

Medical Devices

Hologic BioZorb Marker Recall Class 1: FDA

FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.

Human Drugs

UCB Minzasolmin Parkinsons Study Misses Endpoints

UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, after the drug missed ...

Medical Devices

FDA Alert on Baxter Solution Sets

FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide c...

Human Drugs

Lexicon Dropping Zynquista After CRL

Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.

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

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

Sombra Cosmetics CGMP Violations

FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.