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FDA Clears K2M Yucon Spinal System

[ Price : $8.95]

FDA clears a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixa...

HHS Secretary Price Resigns Amid Chartered Aircraft Scandal

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HHS secretary Tom Price resigns amid a furor over his use of expensive private chartered aircraft for government travel.

Divis Laboratories Inspection Observations

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FDA releases the FDA-483 containing six observations from an inspection at Indias Divis Laboratories.

FDA Issues Emerging Tech Application Guidance

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FDA finalizes a guidance to help drug companies wanting to participate in a program to include emerging technology in specified re...

FDA Seeks Non-voting Members for Device Advisory Panels

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Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting in...

FDA Safety Alert on Endovascular Graft Systems Leaks

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FDA alerts vascular surgeons about Type IIIa and IIIb endoleaks with the use of endovascular graft systems for aneurysm repair pro...

Lilly Gains Approval for Verzenio for Breast Cancer

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FDA approves an Eli Lilly NDA for Verzenio (abemaciclib) for treating adult patients who have hormone receptor-positive, human epi...

FDA Clears Expanding Orthopedics Cage

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FDA clears an Expanding Orthopedics 510(k) for the FLXfit 15 3D Expandable Cage System for restoring lumbar lordosis while control...

FDA Extending REMS to IR Opioids

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FDA commissioner Scott Gottlieb outlines additional steps the agency is taking to try to cut overall exposure to opioids.

Toxicity Testing, Labeling Guidance Out

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FDA publishes a draft guidance on reproductive toxicity assessments for anti-cancer drugs.