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Info Collection on Device Export Certificates

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Export Certificates for FDA Regulated Produc...

Safety Alert on Hintermann Ankle Replacement

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FDA issues safety alert on a higher-than-expected risk of device failure with DT MedTechs Hintermann Series H3 Total Ankle Replace...

Proposed Wound Product Rule Draws Fire

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Three stakeholder organizations raise many questions about and objections to an FDA proposed rule on wound products.

Fake Weight Loss Drugs Concern Califf

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FDA commissioner Robert Califf expresses concern about fake and compounded weight-loss drugs and the disparity in the availability...

FDA Clears Nevro Sacroiliac Joint Fusion Device

[ Price : $8.95]

FDA clears a Nevro 510(k) for its Nevro1 sacroiliac joint fusion device for treating chronic SI joint pain.

Medtronic Recalls Cerebrospinal Fluid Drain

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Medtronic Neurology recalls its Duet External Drainage and Monitoring System, which is used to drain cerebrospinal fluid (CSF) to ...

U.S. Generally Fastest in New Drug Launches

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An HHS-funded RAND study finds that many new drugs are available in the U.S. before launching in other countries.

Baxter Debarment Reduced by 3 Years

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Federal Register notice: FDA issues an order to reduce a five-year debarment against former Indivior global medical director Timot...

Supreme Court Could Hit FDA Regulation: FDLI

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A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely...

Priority Review Granted for Galactosemia NDA

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FDA accepts for priority review an Applied Therapeutics NDA for AT-007 (govorestat) for treating classic Galactosemia.