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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...

Human Drugs

Appeals Court Remands Elements of Clomid Case

The 10th Circuit Appeals Court tells a Utah federal court to reconsider portions of a case brought by a couple alleging that their son was born with b...

Medical Devices

FDA Approves Cardiovascular Systems Replacement Saline Pump

FDA approves a Cardiovascular Systems PMA supplement for a redesigned saline pump used as part of its Diamondback 360 Orbital Atherectomy Systems.