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Federal Register

Comments Sought on Third-party Review Extension

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

Human Drugs

20 States Go After Generic Drug Firms for Price Fixing

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

Feds Recover $2.5 Billion in Healthcare False Claims

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

Human Drugs

FDA Expands Drug Safety Contract with Commonwealth Informatics

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

Medical Devices

FDA Clears St Jude Medicals New Cardiac Mapping System

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

Human Drugs

FDA Proposes 6 Bulk Drug Substances for 503A List

FDA releases a final rule with six bulk drug substances to be included on the Section 503A drug compounding bulks list and four substances not to be i...

Attorneys Explain Antikickback Rule

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

Marketing

Web Page Misleads on Tuxarin: FDA

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

Human Drugs

Team Wins $40,000 in Naloxone App Competition

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

Marketing

Professional E-mail Misbrands Renacidin

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