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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites OsteoSymbionics, Steris, and Vanderveer Center.

FDA Clears Orthovita Bone Graft Substitute

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FDA clears an Orthovita 510(k) for its Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler...

Info on Adverse Event Pilot Program Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on an adverse event pilot program to the Office of Manag...

OMB Approves Info on Electronic Products

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on general requirements for...

OMB OKs Info on Prohibited Animal Feed Substances

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on substances prohibited fr...

Annual Guidance Agenda Released

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Federal Register Notice: FDA publishes its annual guidance document agenda and seeks input on possible future topics.

Compliance Guide on Lasers Withdrawn

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Federal Register Notice: FDA withdraws an obsolete compliance policy guide on lasers as medical devices for facelift, wrinkle remo...

Augmentin Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that three Augmentin drug products were not withdrawn for reasons of safety or effectivene...

Gleevec Capsules Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Gleevec capsules, 50 mg and 100 mg were not withdrawn from sale for reasons of safety...

Workshop on Medical Product Surveillance

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Federal Register Notice: FDA plans a public workshop: Third Annual Sentinel Initiative Public Workshop.