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FDA Debars Drug Wholesaler Rick Shepard

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Federal Register notice: FDA issues an order debarring Rick Shepard for five years from importing or offering for import any drug ...

Panel to Hear Classifications for 6 Preamendment Devices

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Federal Register notice: FDA announces a 6/3-4 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that ...

Revised Guide on Device Premarket Cybersecurity Soon

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CDRH cybersecurity policy analyst Matthew Hazelett says the Center expects to release by the end of the year an updated draft guid...

Oncologic Panel to Vote on Incyte BLA

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Federal Register notice: FDA announces a 6/24 Oncologic Drugs Advisory Committee that will discuss an Incyte BLA for retifanlimab ...

Biogen Therapy for Retinal Disease Misses Endpoint

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Biogen says its Phase 2/3 XIRIUS study of cotoretigene toliparvovec, a gene therapy being investigated for patients with X-linked ...

Indivior Pays $300 Million in Suboxone Marketing Case

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Idaho attorney general Lawrence Wasden announces that an agreement was reached between all 50 states and Indivior that requires it...

Zoll IDE for TherOx SuperSaturated Oxygen Study

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FDA approves a Zoll Medical IDE for a randomized prospective study evaluating the use of TherOx SuperSaturated Oxygen Therapy in p...

ICH Guide Seeks to Reduce Rat Studies

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The International Council for Harmonization releases its Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceutica...

Environmental Impact Statement for Certain Sunscreens

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Federal Register notice: FDA announces its intent to prepare an environmental impact statement to evaluate the potential environme...

5 GDUFA 3 Reauthorization Meeting Summaries

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FDA releases summaries highlighting topics discussed at five GDUFA 3 reauthorization meetings.