The FDA yesterday announced the establishment of its Office of New Drug Quality Assessment (ONDQA), a newly created division of the Office of New Drug Chemistry (ONDC) within the FDA's Office of Pharmaceutical Science.
"ONDQA is being created to facilitate the implementation of a modern, risk-based pharmaceutical quality assessment system to replace the current chemistry, manufacturing and controls (CMC) review system in ONDC," the FDA said in a statement. "ONDQA will be responsible for evaluating CMC section of an IND, NDA, and NDA supplement for drugs regulated by CDER."
The new office will become effective November 1, 2005 and will be headed by Moheb Nasr, currently serving as director, ONDC.
"ONDQA is a science-based organization designed to be more efficient, effective, and flexible in managing CMC issues and workload," said FDA spokeswoman Christine Parker. "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."