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Courts Strengthen Implied Preemption of Drug Changes

[ Price : $8.95]

Attorney Andrew Tauber says two appeals court decisions in the last three years have strengthened implied preemption of state law ...

FDA Pediatric ECG Warehouse Helps Product Development

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FDA says a new pediatric electrocardiogram data warehouse already has almost 40,000 reports to be used in assessing cardiac risk t...

FDA Approves Jardiance for Heart Failure

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FDA approves Boehringer Ingelheim and Eli Lillys diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovasc...

FDA Warning on All Eco-Med Ultrasound Gels

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FDA issues a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by...

Abiomeds Impella Heart Pump Gets Breakthrough

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FDA grants a breakthrough designation to Abiomeds Impella ECP expandable percutaneous heart pump.

Slight Drop in Number of Drug Manufacturing Sites: Report

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The CDER State of Pharmaceutical Quality report for FY 2020 documents a slight decrease in the number of drug manufacturing sites ...

FDA Signals NDA Path for Virpax Nasal Anti-viral Barrier

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FDA tells Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray un...

Intended Use Final Rule Analyzed

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Attorney Jeffrey Shapiro says the FDA final regulation on intended use is a modest improvement over past practice.

FDA Says Purple Wristbands, Bracelets Only for DNR

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FDA recommends hospitals standardize their use of purple medical device bracelets or wristbands to only signify Do Not Resuscitate...

Tempus PMA for xT-Onco Assay

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Tempus files a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare p...