CDER Creates Office of New Drug Quality Assessment

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ePT--the Electronic Newsletter of Pharmaceutical Technology

CDER Creates Office of New Drug Quality Assessment

US Food and Drug Administration Center for Drug Evaluation and Research (Rockville, MD, CDER) Director Stephen K. Galson announced Tuesday the official establishment of the Office of New Drug Quality Assessment (ONDQA), effective Nov. 1. The new office is being formed from the Office of New Drug Chemistry (ONDC), part of the CDER’s Office of Pharmaceutical Science.

“ONDQA is being created to facilitate the implementation of a modern, risk-based ‘pharmaceutical quality assessment system’ (PQAS) to replace the current CMC review system in ONDC,” the announcement said. Moheb Nasr (currently director of ONDC) will head the new ONDQA, which will evaluate the chemistry, manufacturing, and controls (CMC) sections of investigational new drug (IND), new drug application (NDA), and supplemental NDAs.

“ONDQA is a science-based organization designed to be more efficient, effective, and flexible in managing CMC issues and workload,” Galson said, and it is designed to put into action the principles of agency’s Sept. 2005 report, Pharmaceutical CGMPs for the 21st Century-A Risk-Based Approach.


As Pharmaceutical Technology’s October issue reports (see “FDA Lowers Barriers to Process Improvement” by Laura Bush), the new office is part of a reorganization that will separate premarket reviews (to be handled by ONDQA) from postmarket CMC supplements (now reviewed by 19 chemistry teams in 15 clinical divisions, which will be consolidated into a single office).

–Douglas McCormick