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FDA Guidance on Acute Bacterial Sinusitis Drugs

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A new CDER guidance outlines drug development considerations for products indicated for treating acute bacterial sinusitis.

Agency OKs TriVascular Abdominal Stent Graft

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FDA approves a TriVascular PMA for the Ovation Abdominal Stent Graft System for treating abdominal aortic aneurysms.

FTC Seeks High Court Review in Androgel Settlement

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The FTC petitions the U.S. Supreme Court to review a recent federal appeals court ruling concerning its case against a pay-for-del...

12 New and Revised Med Guides Posted

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FDA posts six new and six revised Medication Guides.

Public Citizen Wants Boxed Warnings for Hypertension Drugs

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Public Citizen petitions FDA to require a Boxed Warning and Medication Guide for 19 hypertension drugs.

Drug Compounder Was Warned by FDA 6 Years Ago

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FDA Webview learns that a drug compounding pharmacy at the center of a fatal meningitis outbreak traced back to steroid injections...

FDA Should Reconsider Classification Guidance: Attorney

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Hyman, Phelps & McNamara attorney Jeffrey Gibbs asks FDA to reconsider its draft guidance on Classification of Products as Drugs a...

FDA Safety and Innovation Act Fell Short: Professors

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Harvard Medical School professors Daniel Kramer and Aaron Kesselheim say the new FDA Safety and Innovations Act could have taken m...

Using Social Media for Drug Adverse Event Trends

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Researchers are using a National Science Foundation grant to determine whether social media postings can be used as an adverse dru...

Apotex Sues FDA Over Compliance Status Report Failure

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Apotex files suit against FDA charging that the agencys alleged failure to record the compliance status of its manufacturing facil...