FDA Related News

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.

Human Drugs

FDA OKs Mesoblasts Ryoncil Cell Therapy

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

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.