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Info on Pediatric Devices Sent to OMB

[ Price : $8.95]

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...

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 ...

FDA OKs eNeura Therapeutics Migraine Device

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FDA approves an eNeura Therapeutics de novo petition to allow marketing of its Cerena Transcranial Magnetic Stimulator, the first ...

PhRMA Seeks More Detail on Antibiotic Non-inferiority Designs

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PhRMA asks FDA to include greater detail on non-inferiority designs that make limited use of statistical inference testing in its ...

Alexion Updates Soliris IV Recall

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Alexion Pharmaceuticals updates a November recall notice for its Soliris Concentrated Sollution IV Infusion to include instruction...