ONDC’s New Risk-Based Pharmaceutical

CDER’s Office of New Drug Chemistry (ONDC) is responsible for reviewing the chemistry, manufacturing, and controls (CMC) section of new drug applications. Consistent with the CGMPs for the 21 Century Initiative, ONDC is establishing a modern, risk-based pharmaceutical quality assessment system to replace the current CMC review system. The new quality assessment system is intended to address the multiple challenges and difficulties facing the ONDC and to establish a framework to facilitate continuous CMC improvement and innovation in the pharmaceutical industry.