FDA Related News

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

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

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...