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Medical Devices

Medical Technology Enforcement Nets $1.9 Billion

Skadden Arps attorneys look at the six-year history of Justice Department enforcement actions against medical technology companies that brought $1.9 b...

Medical Devices

NASA Ventilator Gains Emergency Use Authorization

FDA grants an emergency use authorization for a new high-pressure ventilator developed by NASA engineers for treating coronavirus patients.

Human Drugs

Vascular Solutions Recalls Langston Catheter

Vascular Solutions recalls the Langston Dual Lumen Catheter due to the potential for the inner catheter to separate during use.

Medical Devices

CME America Removing Recalled Infusion Pumps

CME America decides to remove from the market all recalled (Class 1) BodyGuard Infusion Pump Systems because they may under or over infuse medications...

Human Drugs

GSK Consumer Recalls 5 Lots of Benefiber Prebiotic

FDA says GSK Consumer is recalling five lots of two Benefiber prebiotic powder products that may contain plastic pieces or shavings from bottle caps i...

Federal Register

New Meeting Date for FDA Data Strategy

Federal Register notice: FDA announces a new date, 6/30, for an earlier postponed public meeting entitled Modernizing FDAs Data Strategy.

Human Drugs

Bipartisan Cures 2.0 Concept Paper Out

Reps. DeGette and Upton release a bipartisan concept paper on Cures 2.0 with eight items that FDA would be expected to do.

Federal Register

Workshop on Generic Regulatory Science Initiatives

Federal Register notice: FDA announces that a 5/4 public workshop entitled FY2020 Generic Drug Regulatory Science Initiatives is being modified to tak...

Human Drugs

AAPS Seeks End to Arizona Prohibition on Chloroquine

The Association of American Physicians and Surgeons asks Arizona governor Doug Ducey to rescind a month-old moratorium forbidding prophylactic use of ...

Medical Devices

FDA OKs Medtronic Pediatric Dialysis Device

FDA authorizes Medtronic to market its Carpediem continuous renal replacement therapy system for use in certain pediatric patients.