Podcast: A Conversation with FDA’s OPQ Director Michael Kopcha
This article was originally published in RPM Report
Executive Summary
Office of Pharmaceutical Quality Director Michael Kopcha discusses the allure of coming to FDA from the private sector and working with CDER Director Janet Woodcock, OPQ’s role in the “Breakthrough Therapy” designation process, the competitive advantages of continuous manufacturing, and priorities for OPQ moving forward.
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