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Panel to Vote on Two PMAs

[ Price : $8.95]

Federal Register Notice: FDAs Gastroenterology and Urology Devices Panel will meet 12/2-3 to discuss Oceana Therapeutics Solesta a...

FDA Science Board for Toxicological Research to Meet

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Federal Register Notice: FDAs Science Advisory Board to the National Center for Toxicological Research will meet 10/19-20 to hear ...

Roche Offers Criteria for IND Combinations

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Roche says FDA should consider two criteria in determining whether to permit two or more new molecular entities in combination dru...

FDA Reviewing AstraZeneca NDA for Thyroid Cancer Drug

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FDA accepts for review an AstraZeneca NDA for its investigational drug vandetanib, indicated for treating patients with advanced m...

FDA Explains Rotarix Labeling Change

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CBER says labeling for GlaxoSmithKlines Rotarix has been updated to include postmarketing trial information suggesting an increase...

FDA Avandia Memos Show Contentious Debate on Safety

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A reading of FDA safety review memos for Avandia illustrates the difficult internal debate the agency constantly faces in its post...

Mylan's Generic Prograf Approved by FDA

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FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Astellas' Prograf capsules used in preventing organ transplant ...

White Paper Raises FDA Monoclonal Antibody Questions

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Parexel Consulting says companies developing follow-on biologics are interested in how FDA will treat monoclonal antibodies.

FDA Approves Gilenya for MS Relapses

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FDA approves Novartis Gilenya for reducing multiple sclerosis relapses and delaying disability progression.

IRB Problems at Bay Regional Medical Center

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FDA warns Bay Regional Medical Center of failures of its IRB to protect human subjects.