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FDA Proposing New Intended Use Definition

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An Inside Medical Devices analysis says drug and medical device companies should consider and comment on a proposed regulation rev...

Industry Needs More Time for Analytical Control Strategies: GPhA

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The Generic Pharmaceutical Association says a significant investment of time and resources is required to establish an analytical ...

FDA Accepts Sanofi NDA for New Diabetes Drug

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FDA accepts for filing a Sanofi NDA for lixisenatide, an investigational once-daily prandial GLP-1 receptor agonist for treating a...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Medsource, New Dawn Nutrition, Specialty Medicine Compounding, and Ultroid Techn...

Guidance on Generic Drug Correspondence with FDA

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Federal Register Notice: FDA releases a guidance: Controlled Correspondence Related to Generic Drug Development.

ICH Guidance on Good Clinical Practice

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Federal Register Notice: FDA releases an ICH guidance: E6(R2) Good Clinical Practice.

FDA Posts Approved PMAs

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Federal Register Notice: FDA publishes a list of 13 PMAs that have been approved including safety and effectiveness summaries.

FDA Issues Priority Review for Xuriden

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Federal Register Notice: FDA issues a priority review voucher to Wellstat Therapeutics for the pediatric disease product applicati...

Pondimin, Ponderex Withdrawn for S&E

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Federal Register Notice: FDA determines that Pondimin and Ponderex were withdrawn from sale for reasons of safety or effectiveness...

FDAs Amarin Problems Traced to Caronia Decision

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Skadden attorneys say that FDAs failure to appeal its off-label promotion case in United States v. Caronia led to a federal judges...