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Device Product Name Corrected

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Federal Register Notice: FDA makes a correction to a product name in a 12/7 Federal Register notice for the NeuroPace RNS System.

FDA Accepts Modular PMA Shell for Intercept Plasma

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FDA accepts a Cerus Corp. modular PMA shell proposal for the Intercept Blood System for plasma.

Lilly Scraps a Phase 3 Tabalumab Study Over Efficacy

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Eli Lilly stops one of three Phase 3 rheumatoid arthritis registration studies involving tabalumab, an anti-BAFF monoclonal antibo...

Guidance Out on Design Considerations for Home Use Devices

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Federal Register Notice: FDA releases a draft guidance, Design Considerations for Devices Intended for Home Use.

Jail Terms Needed in Health Fraud Cases, Blumberg Says

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FDA deputy chief counsel for litigation Eric Blumberg calls for greater use of the Park Doctrine and jail terms in healthcare frau...

Ethicon Hemostatic Matrix Recall is Class 1

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FDA says an Ethicon recall of Surgiflo Hemostatic Matrix products due to a packing process issue is Class 1.

30% of Health Care Cost is Wasted: HHS

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Key federal enforcement officials tell an FDLI Conference panel that 30% of health expenditures are lost to waste, including fraud...

FDA Panel Reclassifies Intra-aortic Balloon Pump Devices

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FDAs Circulatory System Devices Panel votes to support the agencys reclassification of intra-aortic balloon pump devices for certa...

Now Alli Joins Plan B to Embarrass FDA into Action?

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Washington commentator Bob Steeves reviews new risk data on orlistat and contrasts its continuing OTC availability to teens with e...

Janssen Files NDA for Diabetes Combo Pill

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Janssen files an NDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate-release metformin to treat pa...