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Guide on Oncology Reproductive Toxicity Testing

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and...

Comments Sought on Opioid Policy Committee

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Federal Register notice: FDA seeks comments or suggestions on issues relevant to the agencys newly established Opioid Policy Steer...

Aegerion Corporate Integrity Agreement Revealing: Attorneys

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A recent corporate integrity agreement between Aegerion Pharmaceuticals and HHS Office of Inspector General provides insights into...

FDA Clears K2M Yucon Spinal System

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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...