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Reject Rexulti Alzheimers sNDA: Public Citizen

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Alleging weak evidence of effectiveness accepted by an advisory committee, Public Citizen calls on FDA to reject an Otsuka/Lundbec...

Name NIH in Drug Patent Applications: GAO

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The Government Accountability Office says the National Institutes of Health should instruct its research and development grant awa...

Xortx to Pursue Accelerated Approval for Xorlo

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Xortx says a meeting with FDA staff provided the information needed to initiate a Phase 3 study of its Xorlo to treat autosomal do...

Device Regulatory Science Tool Catalog Update

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FDA adds three new tools to the Catalog of Regulatory Science Tools to Help Assess New Medical Devices and updates listings for fi...

Califf Recommends FDA Reforms for Pandemic Bill

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FDA commissioner Robert Califf tells a Senate HELP hearing that FDA inspection, diagnostic devices, and supply chain transparency ...

2-Day Workshop on Rare Disease Endpoints

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FDA and the Duke-Margolis Center for Health Policy announce a 6/7-8 public workshop on the agencys Rare Disease Endpoint Advanceme...

Panel to Mull Strain Selection for Covid Vaccine

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Federal Register notice: FDA announces a 6/15 advisory committee to select strain(s) to be included in the Covid19 vaccines for th...

Comments Sought on Nitrosamine Impurities

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Federal Register notice: FDA creates a docket to receive public comments on the identification, assessment, and control of N-nitro...

FDA Novo Nordisk Concizumab Complete Response Letter

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FDA issues a complete response letter for Novo Nordisks concizumab, asking for additional dosing and manufacturing information.

FDA Warning on Contaminated Covid Tests

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FDA issues a warning on SD Biosensors Pilot Covid-19 At-Home Tests due to bacterial contamination concerns with its liquid solutio...