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Review Period Set for AZs Cleviprex

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for AstraZenecas Cleviprex for the purpose of patent extensio...

Draft Guidance on REMS

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Federal Register Notice: FDA releases a draft guidance on the format and content of proposed risk evaluation and mitigation strate...

Mammography QA Panel to Meet

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Federal Register Notice: FDAs National Mammography Quality Assurance Advisory Committee will meet 11/2 to discuss recent guidance ...

Pilot Program to Evaluate Proprietary Names

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Federal Register Notice: FDA announces a two-year pilot program for pharmaceutical firms to evaluate proposed proprietary names to...

Cortheras Relaxin Gets Fast-Track for AHF

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FDA grants fast-track designation to Corthera Inc. for relaxin for treating acute heart failure.

FDA Webview Posts Caraco Consent Decree

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FDA Webview posts the 29-page consent decree between Caraco Pharmaceutical Laboratories and FDA over the firms ongoing GMP trouble...

Bayer Medicated IUD Approved to Control Bleeding

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FDA approves Bayer Healthcare Pharmaceuticals medicated Mirena contraceptive IUD for the additional indication of treating heavy m...

Comments Extended on Tobacco Act

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Federal Register Notice: FDA extends the comment period on the implementation of the Family Smoking Prevention and Tobacco Control...

Companies Heeded FDA Link Warning

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Digital marketing research firm comScore says that use of drug company sponsored links dropped significantly after FDA issued 14 W...

FDA Raises Votrient Risk/Benefit Questions

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FDA asks the Oncologic Drugs Advisory Committee to advise whether GSKs Votrient should be approved, given questions about its safe...