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Former FDAer Dr. Ellis F. Unger Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory Expert

FDA Law Blog

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”). While at FDA, Dr. Unger’s Office oversaw the approval and regulation of scores of new drugs for cardiovascular, renal, neurological, and psychiatric disorders.

Drugs 40
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Nevro’s Spinal Cord Stimulation; Boston’s PINNACLE FLX; NuVasive’s Modulus ALIF; J&J’s VERITAS Vision System; Medtronic’s DCB Catheter; AngelMed’s Heart Attack Warning System

Delveinsight

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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Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

In the process of hiring select people with extensive commercial experience in Europe and preparing for post-approval market access negotiations. Amarin is optimistic that the worst period of impact from COVID-19 on the levels of patients seeking ordinary course doctor visits and lab tests may be behind it. million and $30.5

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