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Comments Sought on Tobacco Restrictions

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Federal Register Notice: FDA seeks comments on a collection of information on restrictions on the sale and distribution of cigaret...

FDA Approves Subcutaneous Heart Defibrillator

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FDA approves a Cameron Health PMA for the S-ICD System, a heart defibrillator with leads that can be subcutaneously implanted inst...

Drug Shortages Staff to Move to CDER Deputy Oversight

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CDER proposes to elevate the oversight of its Drug Shortages Staff (DSS) from the Office of New Drugs to the Office of the Center ...

Ulcerative Colitis Indication for Humira Approved

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FDA approves an expanded indication for Abbotts Humira (adalimumab) to include treating moderate-to-severe ulcerative colitis in a...

Final Guidance on Bronchitis Drug Development

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FDA finalizes a 2008 guidance on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonar...

7 Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that seven drug products were not withdrawn from sale for reasons of safety or effectivene...

FDA Accepts a BMS Resubmission of Eliquis NDA

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FDA accepts as a complete response a Bristol-Myers Squibb resubmission of Eliquis for patients with nonvalvular atrial fibrillatio...

Patient Centered Outcome Research Proposals Target Priorities

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The Patient Centered Outcomes Research Institute says it has received 483 applications for first cycle research funding that addre...

Bill Would Create FDA Office of Mobile Health

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Rep. Mike Honda says he will introduce a bill to create an Office of Mobile Health in FDA.

Biogen Idec, Swedish Orphan Plan BLA for Clotting Factor

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Biogen Idec and Swedish Orphan Biovitrum say they plan to submit a BLA early next year for their investigational blood clotting fa...