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FDA Approves, Denies Xeloda Labeling Change Petition

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FDA approves some changes to labeling for Xeloda and fluorouracil injection to clarify the risk of severe adverse reactions in pat...

FDA Approves Gores Tigris Vascular Stent

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FDA approves a W.L. Gore & Associates PMA for the Gore Tigris Vascular Stent, a dual-component stent with a fluoropolymer/nitinol ...

Pfizer Settles Celebrex/Bextra Suit for $486 Million

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Pfizer agrees to a $486 million settlement with shareholders for allegedly concealing safety risks associated with its Celebrex an...

IRB Written Procedures Guidance Out

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FDA and HHS issue a joint guidance on institutional review board written procedures.

FDA Takes 1st Steps Regulating 3D Printing

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K&L Gates attorneys outline the major provisions in an FDA draft guidance on additive manufacturing or 3D printing.

ADMA Bio Gets Complete Response Letter on BLA

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FDA gives ADMA Biologics a complete response letter for a BLA for RI-002, an investigational therapy for treating primary immunode...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Specialty Pharmacy, CellOxess, Hsus Ginseng Enterprises, New Horizon Nu...

Guidance on IRB Written Procedures

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Federal Register Notice: FDA releases a draft guidance document: Institutional Review Board (IRB) Written Procedures: Guidance for...

Samsca Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Samsca tablets, 60 mg were not withdrawn from sale for reasons of safety or effective...

Guidance on Blood Donors for Autologous Use

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Federal Register Notice: FDA releases a guidance: Determining Donor Eligibility for Autologous Donors of Blood and Blood Component...