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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...

Why Use Criminal Investigators on Non-criminal FDA Staff Probes?

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House Republicans ask FDA commissioner Margaret Hamburg why the agency is the only HHS unit that uses criminal investigators to pr...

Cardiac Profiler into Class 2

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Federal Register Final rule: FDA classifies cardiac allograft gene expression profiling test systems into Class 2 with a guidance ...