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FDA Explains Rotarix Labeling Change

[ Price : $8.95]

CBER says labeling for GlaxoSmithKlines Rotarix has been updated to include postmarketing trial information suggesting an increase...

FDA Avandia Memos Show Contentious Debate on Safety

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A reading of FDA safety review memos for Avandia illustrates the difficult internal debate the agency constantly faces in its post...

House Passes Bill to Ban Execs Involved in Medicare Fraud

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The House passes H.R. 6130 Strengthening Medicare Anti-Fraud Measures Act that would ban corporate executives from doing business ...

Guidance on IVDs for H. pylori

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Federal Register Notice: FDA releases a draft guidance on 510(k) submissions for various types of in vitro diagnostic devices indi...

Panel to Vote on Two PMAs

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Federal Register Notice: FDAs Gastroenterology and Urology Devices Panel will meet 12/2-3 to discuss Oceana Therapeutics Solesta a...

FDA Science Board for Toxicological Research to Meet

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Federal Register Notice: FDAs Science Advisory Board to the National Center for Toxicological Research will meet 10/19-20 to hear ...

IRB Problems at Bay Regional Medical Center

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FDA warns Bay Regional Medical Center of failures of its IRB to protect human subjects.

DDMAC Enforcement Letters Skyrocket Since Last Year

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DDMAC exceeds last year's totals for issuing Warning and untitled letters sent to pharmaceutical marketers for violating agency ad...

FDA 'Priority' Review for Abuse-resistant Pain Drug

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FDA grants a priority review for an Endo Pharmaceuticals NDA for its new oral formulation of long-acting pain drug oxymorphone.

BMS Overcharged PA $27.6 Million: Judge

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A Pennsylvania state judge says Bristol-Myers Squibb owes the state $27.6 million in overcharges for drugs purchased for state hea...