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Nominations Sought for Device Panels

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Federal Register Notice: FDA requests both nominations and participants in the selection process for nonvoting industry representa...

Abbott's Next Generation Xience Stent Approved

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FDA approves Abbott's next-generation Xience Prime Everolimus-Eluting Coronary Stent System for treating coronary artery disease.

LDR Lumbar Fusion Device Cleared

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FDA clears an LDR 510(k) for the ROI-A Oblique ALIF cage and its use in lumbar fusion surgery.

Senate Passes FDA Budget with $50 Million Increase

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The U.S. Senate approves a bill that would boost FDAs FY 2012 budget by $50 million, most of it going to food safety initiatives.

Somaxon Seeks Restrictions on Generic Silenor ANDAs

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Somaxon asks FDA not to approve ANDAs for generic Silenor than dont meet bioequivalence requirements sought by the company.

Info on Veterinary Feed Directive Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the veterinary feed directive to the Office of Manage...

Workshop on Pediatric Device Claims

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Federal Register Notice: FDA plans a public workshop 12/5 on using scientific research data to support pediatric medical device cl...

WLF Urges Reinstatement of Viropharma Suit

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The Washington Legal Foundation urges an appeals court to reinstate a dismissed lawsuit challenging an FDA rule that makes it easi...

Comments Sought on Device Labeling

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Federal Register Notice: FDA seeks comments on a collection of information on device labeling.

Group Urges No Anthrax Vaccine Testing in Kids

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Public Citizen says the U.S. government should reject advice from the National Biodefense Science Board to test the anthrax vaccin...