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Draft Guide on sBLA for Biosimilar Use

[ Price : $8.95]

Federal Register notice: FDA announces a draft guidance entitled Biosimilars and Interchangeable Biosimilars: Licensure for Fewer ...

Info Collection Extension for PMA Devices

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Federal Register notice: FDA sends to OMB an information collection extension for Premarket Approval of Medical Devices.

GE Recalls Carestation Anesthesia Systems

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GE Healthcare recalls the Carestation 600 Series Anesthesia Systems because there is a potential for a loose cable connection whic...

Workshop on Multi-Component Biomarkers

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FDA announces a 3/23 public workshop on multi-component biomarker concepts and terminology.

HIV Resistance Assay Put in Class 2

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Federal Register notice: FDA classifies human immunodeficiency virus drug resistance genotyping assays using next generation seque...

Senators Query FDA on Coronavirus Resources, Shortages

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Two U.S. senators ask FDA whether it has the necessary resources to ensure active pharmaceutical ingredients and other medical pro...

In2Bones Global Total Ankle Cleared

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FDA clears an In2Bones Global 510(k) for the Quantum Total Ankle.

Caption Health AI Cardiac Imaging Software Cleared

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FDA permits the de novo marketing of Caption Healths software to assist medical professionals in capturing cardiac ultrasound or e...

BD Surprised with 510(k) Request for Alaris Fixes

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Becton Dickinson says FDA is requesting that modifications to the Alaris infusion pump will require a 510(k) filing.

Gilead Lends Remdesivir to China for Coronavirus Trial

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Gilead Sciences works with Chinese health authorities to begin a randomized, controlled study to determine whether the companys re...