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Radiological Devices Panel to Meet

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Federal Register Notice: FDAs Radiological Devices Panel will meet 11/17-18 to discuss Full Field Digital Mammography Devices and ...

FDA Clears Collagen Dental Membrane

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FDA clears a Collagen Matrix 510(k) for its Collagen Dental Membrane intended for use in oral surgical procedures involving guided...

FDA Concerned About Spiked Supplements

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FDA principal deputy commissioner Joshua Sharfstein says that steroids are the most high profile safety concern facing the dietary...

Amgen Says Prolia Dealt Another Blow

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FDA issues a second complete response letter this week for a separate BLA for Amgens Prolia (denosumab) and its use treating and p...

FDA Clears Custom Spines Pathway Device

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FDA clears a Custom Spine 510(k) for the Pathway AVID (articulating vertebral interbody device).

FDA Debarments are Still Too Slow: GAO

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GAO says it often has taken FDA many years to complete debarment or disqualification proceedings against clinical investigators wh...

A New Prince on the Block?

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Consulting editor John Scharmann sees the return of former associate commissioner for regulatory affairs John Taylor III as counse...