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CDRH Safety Communications Up

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Qmed Daily says the number of CDRH medical device safety communications this year rose substantially over the numbers in 2014 and ...

Man Sentenced for Continuing to Sell Misbranded Products

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A Livingston, MT man pleads guilty to selling dietary supplements in violation of two court orders, according to a Department of J...

FDA Panel Votes Down Depression Drug

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FDAs Psychopharmacologic Drugs Advisory Committee votes to not recommend approval for a Fabre-Kramer Pharmaceuticals NDA for gepir...

2nd Patient Dies in Zafgen Obesity Trial

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Zafgen says a second death has been reported in a Phase 3 trial of beloranib in patients with Prader-Willi syndrome.

Insulet Safety Alert on OmniPod Insulin Delivery

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FDA says Insulet Corp. has issued a lot-specific voluntary Field Safety Notification for 15 lots of its OmniPod insulin deliverty ...

Cellular Therapy Needs Regulatory Pathway: Report

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A Bipartisan Policy Center report calls on FDA to create a new regulatory pathway that would promote the use of cellular therapy i...

FDA January Workshop on Device Cybersecurity

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FDA announces a two-day (1/20-21/16) public workshop entitled Moving Forward: Collaborative Approaches to Medical Device Cybersecu...

Alcresta Pharmas Relizorb De Novo Petition Approved

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FDA approves a de novo petition from Alcresta Pharmaceuticals to market Relizorb (immobilized lipase), a digestive enzyme cartridg...

European Regulators Looking at Califf Trial: POGO

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The Project on Government Oversight says a European drug regulator is looking into reports that a clinical trial for Janssens Xare...

Reflect 1st Amendment in Intended Use: WLF

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Washington Legal Foundation says FDAs proposed revised regulations on intended uses of drugs and medical devices should reflect cu...