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Dispute Panel to Discuss Acorn Device

[ Price : $8.95]

Federal Register Notice: FDAs Medical Devices Dispute Resolution Panel will vote on a dispute between FDA and the Acorn Corp. on i...

Dingell Promises FDA Drug Safety and Generics Oversight

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House Committee on Energy and Commerce incoming chairman John Dingell (D-MI). says next Congress will examine issues involving Med...

More Consensus Needed on Genomic Issues: FDA

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CDER senior staff Federico Goodsaid calls for greater consensus on biomarkers, study protocols, and biological interpretations rel...

Updated Breast Implants Guidance

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Federal Register Notice: FDA releases a guidance on Saline, Silicone Gel, and Alternative Breast Implants.

Guidance on Sinusitis Treatments

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Federal Register Notice: FDA releases a draft guidance on designing clinical development programs for nonantimicrobial drugs to tr...

Rare Dispute Resolution Panel to Hear Acorn Appeal

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CDRHs Medical Devices Dispute Resolution Panel meets next month for the second time in nine years, to discuss scientific issues re...

Appeals Court to Rehear Experimental Drug Access Case

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The U.S. Court of Appeals for the District of Columbia agrees to rehear a case that found terminally ill patients should have acce...

Decorative Contact Lenses Are Rx Only

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A new FDA guidance says decorative contact lenses are subject to 510(k) or PMA clearance before they can be marketed.

FDA OKs Teva and SICOR Generic Zofran

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FDA approves ANDAs from Teva and SICOR Pharmaceuticals for the first generic copies of GlaxoSmithKlines Zofran.

Seroquel Sales Aid False and Misleading

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DDMAC sends AstraZeneca a notice of violation for a Seroquel professional sales aid that it says omits relevant risk information.