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Workshop on Pediatric Device Claims

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Federal Register Notice: FDA plans a public workshop 12/5 on using scientific research data to support pediatric medical device cl...

WLF Urges Reinstatement of Viropharma Suit

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The Washington Legal Foundation urges an appeals court to reinstate a dismissed lawsuit challenging an FDA rule that makes it easi...

Senate Passes FDA Budget with $50 Million Increase

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The U.S. Senate approves a bill that would boost FDAs FY 2012 budget by $50 million, most of it going to food safety initiatives.

Group Urges No Anthrax Vaccine Testing in Kids

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Public Citizen says the U.S. government should reject advice from the National Biodefense Science Board to test the anthrax vaccin...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cagenix and Laura Teasley.

Perrigo Drug Preemption Case Goes Back to Appeals Court

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The Supreme Court tells an appeals court to reconsider its ruling that Perrigo could comply with both state and federal laws speci...

Comments Sought on Device Labeling

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Federal Register Notice: FDA seeks comments on a collection of information on device labeling.

FDA Corrects Notice on Cigarette Package Warnings

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Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the guidance on required warnings f...

CDRH Report Examines Barriers to Device Quality

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A new CDRH report says greater visibility on the agency's expectations of device quality and properly aligning its regulatory appr...

Vytorin Reduces CV Events in Kidney Disease Patients: FDA

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FDA says clinical data suggest that Merck/Schering Ploughs Vytorin (ezetimibe and simvastatin) is effective in reducing the risk o...