Expedited Program Quality Assessment MAPP

The CDER Office of Pharmaceutical Quality (OPQ) has issued a Manual of Policies and Procedures, Quality Assessment for Products in Expedited Programs, outlining policies and procedures that are intended to facilitate and expedite the development, time to submission, assessment, and marketing approval of NDAs and BLAs for products that address unmet needs in the treatment of serious or life-threatening conditions. OPQ says the document is intended to help fulfill the Chemistry, Manufacturing, and Controls (CMC) readiness commitments in the PDUFA 7 commitment letter. It also supports the CMC readiness pilot program outlined in the letter.

“Overcoming CMC challenges to achieve earlier patient access to these products often requires additional interactions with FDA and the use of science-based and risk-based regulatory approaches,” OPQ says. “This MAPP provides information on OPQ’s use of regulatory flexibilities … to help overcome CMC readiness challenges.