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FDA revamps CMC review

This article was originally published in The Tan Sheet

Executive Summary

The Office of New Drug Quality Assessment has been established to replace FDA's Office of New Drug Chemistry and will become effective Nov. 1, the agency announces Oct. 5. ONDQA will operate within the Office of Pharmaceutical Science to help implement a "risk-based pharmaceutical quality assessment system" to replace the current chemical, manufacturing and controls (CMC) review process. ONDQA is "designed to be more efficient, effective, and flexible in managing CMC issues and workload," the agency adds. The new office will review the CMC section of Investigational New Drug applications, New Drug Applications and NDA supplement applications. ONDQA will be headed by Moheb Nasr, PhD, who currently serves as ONDC director...
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