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Stakeholders Back, Oppose Proposed UDI Exemptions

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Stakeholders differ on whether FDA should exempt some devices from UDI requirements.

FDA Posts Latest Drug Safety Evaluation Summaries

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FDA posts summaries of 37 drug safety evaluations opened during the first half of 2012.

OTC Bronchodilator Labeling Guidance Out

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FDA publishes a question-and-answer guidance to help small businesses understand and comply with labeling requirements for broncho...

AMA Wants to End Pay-for-Delay

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The American Medical Association calls for an end to pay-for-delay agreements that can slow the marketing of generic drugs.

FDA Clears Vital Images 3-D Medical Viewer

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FDA clears a Vital Images 510(k) for three-dimensional viewing and computer tablet viewing through its universal viewer VitreaView...

Enhanced Communication Team Works with Drug Sponsors

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FDA publishes a PDUFA notice on the work of the CDER enhanced communication team.

Forest, Ademas to Develop Fixed Dosed Alzheimers Treatment

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Forest Laboratories and Adamas Pharmaceuticals enter into an agreement to develop a fixed dosed combination of Namenda XR and done...

FDA Publishes Notice of FDA User Fee System Records

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Federal Register Notice: FDA publishes notice of a system of records entitled, FDA User Fee System, HHS/FDA.

Hamburg in Hot Seat at Drug Compounding Hearing

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Democratic senators and House Energy and Commerce Committee Republican members take aim at FDA in separate Hill hearings and criti...

FDA Rejects Xyrem ANDA Bioequivalence Request

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FDA denies a Jazz Pharmaceuticals citizen petition asking that it publish bioequivalence requirements for any ANDA for a generic f...