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Congress Should Redefine Drug, Device: Attorney

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Attorney Suzanne OShea says Congress needs to clarify its intent so FDA knows how to classify combination products for review eith...

CDRH-backed Single Audit Program Up and Running

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CDRH associate director for international affairs Kimberly A. Trautman says an FDA-backed medical device single audit program shou...

White House Antibotic Resistance Report Out

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President Obamas science and technology advisors release a report and strategy on combating antibiotic resistance.

FDA Clears da Vinci Systems in Tongue Resection

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FDA clears an Intuitive Surgical 510(k) for its da Vinci S and da VinciSi Surgical Systems and their use in benign, base-of-tongue...

FDA Approves Eli Lillys New Diabetes Drug

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FDA approves an Eli Lilly NDA for Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control in adu...

FDA Panel Votes Down Clarus Therapeutics Rextoro

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A joint FDA advisory committee panel votes 18-3 that the overall benefit/risk profile of Rextoro (testosterone undecanoate) was no...

FDA Proposes Salivary System into Class 2

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Federal Register Proposed order: FDA proposes to reclassify salivary stimulatory system into Class 2.

Tryptase Test System into Class 2

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Federal Register Final order: FDA classifies tryptase test system devices into Class 2.

FDA Approves New Erectile Dysfunction Indication for Stendraa

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FDA approves Vivus and Auxiliums Stendraa as an erectile dysfunction treatment that may be taken as early as 15 minutes before sex...

FDA Extends Review of Impax Parkinsons Drug

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FDA extends by three months its review of an Impax Pharmaceuticals NDA resubmission for Rytary (carbidopa and levodopa), an invest...