News

Posted On: 10/05/2005

FDA's CDER Creates Office of New Drug Quality Assessment

PharmaManufacturing.com

FDA's Center for Drug Evaluation and Research (CDER) on October 4 announced the establishment of the Office of New Drug Quality Assessment (ONDQA) from the Office of New Drug Chemistry (ONDC) within the 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.

ONDQA will be headed by Dr. Moheb Nasr, who is currently serving as Director, Office of New Drug Chemistry. The new office will be responsible for evaluating the chemistry, manufacturing, and controls (CMC) section of an IND, NDA, and NDA supplement for drugs regulated by CDER. ONDQA will become effective November 1, 2005.

The new pharmaceutical quality assessment paradigm was described in the September 2004 ONDC White Paper, published as part of the FDA final report on "Pharmaceutical CGMPs for the 21st Century — A Risk-Based Approach."

"ONDQA is a science-based organization designed to be more efficient, effective, and flexible in managing CMC issues and workload," said CDER Director Steven K. Galson, M.D., M.P.H., in an internal memo. "While any new organizational structure is subject to fine-tuning, I believe that the establishment of ONDQA is an important step in the continuing improvement of FDA's CMC review practices for the 21st Century and I look forward to its successful implementation as a solid base on which to build further improvements."