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Info on Pediatric Devices Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on pediatric uses of devices to the Office of Management...

FDA Proposal Cracks Down on Antibacterial Soaps

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A just-released FDA proposed rule aims to require manufacturers of antibacterial hand soaps and body washes to demonstrate that th...

More FDA Regulation Needed for Drug Ads: Researcher

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A University of Pittsburgh researcher says more FDA regulation should be considered to make drug companies do a better job at port...

High Court Punts on First Amendment Case

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The Supreme Court declines to hear a closely watched appeal by former InterMune CEO Scott Harkonen on whether someone can be prose...

K-V Pharma Asks Court to Make FDA Block Makena Compounding

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K-V Pharmaceutical asks the Washington, DC federal appeals court to compel FDA to prevent Chinese unapproved ingredients from ente...

House Lawmakers Introduce Antibiotic Development Bill

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A bipartisan group of U.S. House lawmakers introduces the Antibiotic Development to Advance Patient Treatment Act of 2013.

Advisory Committee Backs BMS Diabetes Drug

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee recommends that the benefits of Bristol-Myers Squibbs diabetes drug dap...

FDA Wants More Data on Janssen Combo Diabetes Drug

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FDA issues Janssen a complete response letter on its NDA for a fixed-dose combination of canagliflozin and immediate-release metfo...

Cadence Seeks Approval Restrictions on Generic Ofirmev Products

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Cadence Pharmaceuticals petitions FDA asking it not to approve any generic or 505(b)(2) NDAs for an acetaminophen solution for int...

Report Looks at Studies in Comparative Effectiveness

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A new government report examines how observational studies contribute to the results and conclusions in comparative effectiveness ...