FDA Related News

Human Drugs

Senators Introduce Skinny Label Generic Drug Bill

Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labeled generics.

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

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.

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.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

Human Drugs

FDA Seeks Comments on ODAC Briefing Guidance

FDA says it will receive comments until 2/28 on a draft guidance on the possibility for cancer drug sponsors and FDA to prepare a joint briefing docum...