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Comment Period Extended on De Novo Classification Guidance

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Federal Register Notice: FDA extends the comment period on a draft guidance on the de novo classification process.

Gilead Seeks New Five-year Data on Viread Labeling

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Gilead Sciences asks FDA to add new Viread (tenofovir disoproxil fumarate) labeling based on five-year data from two open-label Ph...

Appeals Court Rules Against Companies on Grandfathered Drug

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A federal appeals court rules against Cody Laboratories and Lannett Co. in their bid to challenge FDAs Unapproved Drugs Initiative...

FDA Approves Janssen's Xarelto for Stroke Prevention

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FDA approves a Janssen Pharmaceuticals NDA for Xarelto (rivaroxaban), indicated for preventing stroke and systemic embolism in pat...

FDA Reminds Avandia Patients of Access Deadline

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FDA reminds healthcare providers and patients of the 11/17 deadline to enroll in the Avandia-Rosiglitazone Medicines Access Progra...

Will Supreme Court Settle 'Off-label Promo Conundrum?

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FDA watchers hope the U.S. Supreme Court will soon put to rest First Amendment arguments surrounding the agencys restrictions on o...

FDA Allows Octagam Back on the Market

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FDA approves the market return of Octapharmas Octagam [immune globulin intravenous (human) 5% liquid preparation] for use in treat...

Carefusion Class 1 Recall of Ventilator

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CareFusion recalls its EnVe Ventilator after identifying potential defects that can interrupt ventilation to patients.

Genentech FDA-483 Cites Avastin Manufacturing Deficiencies

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A September FDA inspection of a Genentech facility cites the firm for deficiencies related to Avastin's manufacturing.

RegeneRx Plans Meeting with FDA on Dry Eye Drug

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RegeneRx Biopharmaceuticals says it plans to confirm with FDA outcome measures for an upcoming Phase 3 study involving its dry eye...