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2 Former Insys Execs Sentenced Over Opioids

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Two former Insys sales executives are sentenced to federal prison sentences for their role in a bribery and kickback scheme to pro...

Zhuhai Aofute Medical Technology CGMP Violations

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FDA warns Chinas Zhuhai Aofute Medical Technology Co. about CGMP and other violations in its manufacturing of finished drugs.

FDA Launching Drug Risk Management Board

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CDER launches its Drug Risk Management Board to facilitate rapid analysis and resolution of drug safety issues throughout the Cent...

Clinical Performance Assessment Guidance

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FDA publishes a guidance on computer-assisted detection devices applied to radiology images and radiology device data.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes CGA Limited, Curewave Lasers, Tismor Health and Wellness, Vevazz an...

FDA Approves Horizons Rare Eye Disease Drug

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FDA approves a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease.

GAO on More Drug Development Machine Learning

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A Government Accountability Office report describes six policy options for overcoming challenges to increasing the use of machine ...

Office of New Drugs Name Changes

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CDER says names of the Office of New Drugs offices and divisions were changed as part of its reorganization.

Medtronic Smallest Pacemaker w/AV Synchrony OKd

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FDA approves a Medtronic PMA for the Micra AV, which it describes as the worlds smallest pacemaker with atrioventricular synchrony...

CGMP Violations at Tismor Health and Wellness

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FDA warns Australias Tismor Health and Wellness about CGMP and other violations in its work as a contract manufacturer of finished...