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Janssen Biotech sBLA for Stelara in Adolescents

[ Price : $8.95]

Janssen Biotech files a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age...

FDA Allows Pfizer to Remove Boxed Warning From Chantix

[ Price : $8.95]

FDA approves updates to Pfizers Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric e...

Feds Recover $2.5 Billion in Healthcare False Claims

[ Price : $8.95]

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.