CMC Workshop

FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that using such technologies could result in delays while FDA reviewers familiarize themselves with the new technologies and determine how they may be evaluated within the existing regulatory framework. To address these concerns, CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. Through the program, 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. This session will describe updates and recent challenges associated with the Program.