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FDA Wants Statistical Analyses on Sex Differences in Device Studies

[ Price : $8.95]

FDA recommends device makers perform a statistical analysis based on gender for completed studies, according to a just-published f...

Guidance on Unique Device ID System

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Federal Register Notice: FDA releases a guidance: Unique Device Identification System: Small Entity Compliance Guide.

FDA Panel Rejects Actavis Hypertension Combo Drug

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FDAs Cardiovascular and Renal Drugs Advisory Committee votes to recommend against approval of an Actavis NDA for a fixed-dose comb...

Texas Jury Orders Boston Scientific $73 mil. Payment

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A Texas state jury awards a woman $73 million in damages for injuries suffered from a Boston Scientific transvaginal mesh device.

Web Site Promotes Unapproved New Drugs: FDA

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FDA warns CreAgri that its two Web sites are making drug claims for four Olivenol-branded unapproved drug products.

Biosimilars Orange Book is Purple

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FDA publishes its Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Inter...

U.S. Files Charges Against Reliance Medical, Others

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The Justice Department files two complaints under the False Claims Act against Michigan neurosurgeon Aria Sabit, spinal implant co...

Some Pro-sponsor Advisor Voting Bias Found

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Researchers writing in Milbank Quarterly say there appears to be a pro-sponsor voting bias among CDER advisory committee members w...

No Surprises in InFuse Decision

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A Drug and Device Law blog post says a recent Arizona federal court decision in a Medtronic InFuse case tracks existing 9th Circui...

CDER Recruits DoJ Lawyer to Head Compliance Office

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Continuing FDAs recent trend of favoring attorneys to head up its compliance offices, CDER appoints Department of Justice deputy i...