FDA Law Blog

FEBRUARY 21, 2022

Unger has joined the firm as a Principal Drug Regulatory Expert. Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). He completed his cardiology training at The Johns Hopkins Hospital in 1987.

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Delveinsight

AUGUST 3, 2021

Nevro Received FDA Approval of its 10 kHz High-Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy. received approval for its Senza System, Nevro’s unique 10 kHz stimulation, to treat chronic pain associated with Painful Diabetic Neuropathy (PDN).

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The Pharma Data

NOVEMBER 4, 2020

District Court ruling in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to VASCEPA capsules in its initial triglyceride lowering indication. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. promotion of VASCEPA : As reported, the U.S.

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