FDA Risk-Based CMC Review Should Include List Of High-Risk Drugs - PhRMA
Executive Summary
FDA's risk-based chemistry, manufacturing & controls review proposal should include a list of high-risk drugs, Pharmaceutical Research & Manufacturers of America said.
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Oncology Drug Products Division Chemistry Team Leader Eric Duffy, PhD, becomes Division of New Drug Chemistry II director July 8. Duffy "has a particular interest in drug substance manufacturing issues and is a past chair of the Drug Substance Committee," FDA says. He is also involved in the new initiative for risk-management-based chemistry, manufacturing and control review (1"The Pink Sheet" June 25, p. 32)