FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that developing such technologies could result in delays while novel regulatory challenges are considered. This is especially true while FDA assessors familiarize themselves with new technologies and determine how they may be evaluated within the existing regulatory framework. To address these concerns, CDER’s Office of Pharmaceutical Quality (OPQ) created the Emerging Technology Program (ETP).
Established in 2014, ETP is a collaborative program where industry representatives can meet with Emerging Technology Team (ETT) members to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission. ETT members are comprised of representatives from all relevant FDA quality review and inspections programs including OPQ, CDER’s Office of Compliance (OC) and the Office of Regulatory Affairs (ORA).