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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...

Addrenex Submits sNDA to Treat ADHD

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Addrenex Pharmaceuticals submits an sNDA to FDA for Clonicel to treat attention deficit hyperactivity disorder.

Heparin Manufacturing Change Decreases Potency

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FDA announces changes in heparin manufacturing controls mandated by USP that will cause a drop in drug potency with clinical impli...

Penumbra Recalls Delivery Catheter

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FDA says Penumbra has recalled its original version of the Neuron 6F 070 Delivery Catheter due to reports that it could kink in ce...

PegIntron Doesnt Improve Overall Melanoma Survival: FDA

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FDA asks the Oncologic Drugs Advisory Committee whether the benefit of Scherings PegIntron in providing some relapse-free survival...

CSPI Sues Bayer Over Vitamin Selenium Cancer Claim

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The Center for Science in the Public Interest sues Bayer for refusing to remove all ad claims for Mens One A Day multivitamins cla...

Combo Products Postmarket Regs Proposed

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Federal Register Proposed rule: FDA proposes postmarketing safety reporting requirements for combination products.

Review Period Set for AZs Cleviprex

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Draft Guidance on REMS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Federal Register Notice: FDA releases a draft guidance on the format and content of proposed risk evaluation and mitigation strate...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