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Comments Sought on Third-party Review Extension

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Third-Party Review Under the ...

20 States Go After Generic Drug Firms for Price Fixing

[ Price : $8.95]

The attorneys general from 20 states file a federal lawsuit that alleges six pharmaceutical companies violated antitrust laws by c...

Feds Recover $2.5 Billion in Healthcare False Claims

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The Justice Department says healthcare False Claims Act recoveries totaled $2.5 billion in FY 2016.

FDA Expands Drug Safety Contract with Commonwealth Informatics

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FDA and Commonwealth Informatics sign a new contract to support the use of advanced drug safety review tools at CDER and CBER.

FDA Clears St Jude Medicals New Cardiac Mapping System

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FDA clears a St. Jude Medical 510(k) for its EnSite Precision cardiac mapping system and Advisor FL Circular Mapping Catheter, Sen...

FDA Proposes 6 Bulk Drug Substances for 503A List

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FDA releases a final rule with six bulk drug substances to be included on the Section 503A drug compounding bulks list and four su...

Attorneys Explain Antikickback Rule

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Two Hyman, Phelps attorneys explain provisions in a new HHS Inspector General final rule on antikickback safe harbors and civil mo...

Web Page Misleads on Tuxarin: FDA

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CDERs Office of Prescription Drug Promotion warns Spriaso about a Tuxarin ER Web page that gives false and misleading risk informa...

Team Wins $40,000 in Naloxone App Competition

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FDA associate commissioner Peter Lurie says the winner of an FDA-sponsored Naloxone App Competition was OD Help, created by Team P...

Professional E-mail Misbrands Renacidin

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CDERs Office of Prescription Drug Promotion warns United-Guardian about a professional e-mail that misbrands its Renacidin.