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FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 4/28/2017.

Medical Devices

Medtronic Expands Class 1 Recall of Ventricular Assist Device

Medtronic Mechanical Circulatory Support expands a Class 1 recall involving its Ventricular Assist Device Controllers and DC Adapter to now include al...

Human Drugs

FDA Clears Crospon Endoflip Topography Module

FDA clears a Crospon 510(k) for its Endoflip System with Flip Topography Module, which is intended to assess patient motility disorders during endosco...

FDA General

Science Board to Review Cure Act Work Plan

FDA asks its Science Board for comments on a draft work plan on 21st Century Cures Act Innovation Account Activities that prioritizes patient-focused ...

Human Drugs

Drug Spending Ebbed Last Year: Report

Growth in U.S. spending on prescription drugs drops as competition between manufacturers heats up and payers step up efforts to curb price increases, ...

Human Drugs

FDA Approves Mitsubishi Drug for Lou Gehrigs Disease

FDA approves a Mitsubishi Tanabe Pharma America NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as L...

FDA General

FDA Denies Claims Its Staff May Watch Only Fox News

Media reports indicate the Trump Administration wants Fox News broadcasts to replace CNN on internal video monitors across FDAs White Oak, MD campus, ...

Human Drugs

Dr. Reddys Form 483 Posted on Bachupally, India Inspection

FDA posts a Dr. Reddys Laboratories Form 483 from a 4/28 inspection that cited the firms Bachupally, Hyderabad, India manufacturing facility on 11 obs...

Medical Devices

Medtronic HeartWare Splice Kit Recall is Class 1: FDA

FDA says Medtronics recall of a HeartWare driveline splice kit due to a design defect that could lead to an interrupted electrical connection to a ven...

Human Drugs

FDA Approves Designations for 3 Additional Sangamo Products

FDA grants special regulatory designations to three additional Sangamo Therapeutics products.