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Device Panel to Vote on Lutonix Angioplasty Catheter

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Federal Register notice: FDA announces a 2/17 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Comm...

Priority for Bayer NDA for Kidney/Diabetes Patients

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FDA accepts for priority review a Bayer NDA for finerenone, an investigational drug for patients with chronic kidney disease and T...

FDA Framework for CBD Data Collection

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FDA commissioner Stephen Hahn and principal deputy commissioner Amy Abernathy describe an agency framework for needed research int...

FDA Needs Legal Authority to Regulate Diagnostics: Pew Charitable Trusts

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A Pew Charitable Trusts issue brief calls for legislation to give FDA authority over laboratory-developed tests.

Dont Authorize Florida Drug Import Program: Petition

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Three major healthcare organizations petition FDA not to authorize Floridas drug importation proposal.

HHS Steps on FDAs Feet to Advance 2 Policies

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In the final days of the Trump Administration, HHS treads on FDA turf by unilaterally proposing two last minute policies intended ...

FDA Workshop on Evaluating RWE Observational Studies

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FDA and the Duke-Margolis Center for Health Policy schedule a 2/16-17 virtual workshop on evaluating real-world evidence from obse...

FDA Approves MicroVentions WEB 17 System

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FDA approves MicroVentions WEB 17 system for treating intracranial wide-neck bifurcation aneurysms.

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Bonagens.

FDA/HHS Play Musical Chairs with Chief Counsel Post

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In an apparent rebuke of FDA commissioner Stephen Hahn, HHS overrides his choice of who will temporarily lead the Office of Chief ...