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Researchers Examine Modeling for Pediatric Dose Selection

[ Price : $8.95]

FDA researchers work with industry and clinicians to determine the best way to apply modeling information to improve pediatric dos...

Possible False Positive with Syphilis Test

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FDA alerts clinical laboratory staff and health care providers that false reactivity or a false positive test result is possible w...

FDA Modifies REMS for Mifepristone

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FDA modifies a Risk Evaluation and Mitigation Strategies program for mifepristone, a drug used in early abortion and miscarriage c...

Getinge/Datascope/Maquet Cardiosave Recall is Class 1

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FDA says the Getinge/Datascope/Maquet recall of Cardiosave intra-aortic balloon pumps is Class 1.

Administration Sidelining Vaccine Scientists: Ex-FDAers

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Two former FDA scientists say it is a mistake for FDA and CDC to bypass advisory committees when making Covid vaccine decisions.

Medical Device Integrity Act Introduced

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Sens. Cassidy and Baldwin introduce bipartisan legislation to require medical device manufacturers to comply with FDA record reque...

FDA Updates Off-Patent, Off-Exclusivity List

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FDA updates the list of off-patent and off-exclusivity drugs without an approved generic, adding some over-the-counter products.

Guide on Referencing Definition of Device

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Federal Register notice: FDA makes available a draft guidance on Referencing the definition of device in public documents.

Traumatic Brain Injury Eye Assessor in Class 2

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Federal Register notice: FDA classifies the traumatic brain injury eye movement assessment aid into medical device Class 2 (specia...

Biogen to File Alzheimers Confirmatory Trial Protocol

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Biogen says it will submit a final clinical trial protocol to FDA 3/2022 for a required post-marketing trial of its controversial ...