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MDR, QS Violations Found at MedArt

[ Price : $8.95]

FDA warns MedArt about Medical Device Reporting and Quality System violations found in an inspection at a company manufacturing fa...

FDA Clears Lensar Laser for Corneal Incisions

[ Price : $8.95]

FDA clears a Lensar 510(k) for its laser system for use in executing corneal incisions during cataract surgery.

CDER First-Cycle Approvals Highest in 20 Years: Jenkins

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CDER Office of New Drugs director John Jenkins says the first-cycle approval rate in 2012 is at the highest level in 20 years.

Exact Sciences PMA Module for Colorectal Cancer Screener

[ Price : $8.95]

Exact Sciences Corp. files the first PMA module for its stool DNA colorectal cancer screening test.

Panel to Discuss Janssens NDA for Type 2 Diabetes

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 1/10/13 to discuss Janssens NDA for ...

Cellular, Tissue and Gene Therapies Panel to Meet

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Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 1/15/13 to discuss intramural resea...

Boehringer Ingelheim Reports Phase 2 Volasertib Data in Adults with AML

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Boehringer Ingelheim Pharmaceuticals reports positive preliminary results of a Phase 2 study of volasertib in newly diagnosed pati...

Celldex Phase 2b Study Backs Benefit in Breast Cancer

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Celldex Therapeutics says final results from its Phase 2b EMERGE study of CDX-011 supports overall survival benefit in advanced br...

OIG Urges Action on Investigator Disclosures, Device Safety Events

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An OIG report continues to recommend that FDA require sponsors to submit financial information as part of the pretrial application...

High Court to Review Pay-for-Delay Generic Case

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The U.S. Supreme Court agrees to review recent federal appeals court ruling concerning a Federal Trade Commission case against a p...