FDA Related News

Human Drugs

Quality, Data Issues at Mylan Facility in India

FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.

Human Drugs

Boxed Warning for Veozah Liver Injury

FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.

Human Drugs

Sombra Cosmetics CGMP Violations

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

Human Drugs

FDA OKs Mesoblasts Ryoncil Cell Therapy

FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.

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.

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.

Clinical Investigation Protocol Deviations

FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.

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.