(372a) Chemistry, Manufacturing, and Controls: Early Development and Expediated Programs (invited talk)

As clinical development progresses from submission of an initial investigational new drug (IND) application to a marketing application, manufacturing processes and controls change significantly to support marketing. This presentation will focus on chemistry, manufacturing, and controls (CMC) regulatory requirements throughout clinical development. The presentation will provide an overview of the regulations that govern CMC requirements for an IND application and how the requirements change through clinical development. As part of CMC development, this presentation will discuss FDA interactions with industry through clinical development to facilitate approval of applications that implement new technologies. This presentation will also discuss recent efforts to facilitate the development of products with accelerated clinical development timelines, approaches to address CMC challenges, and the CMC Development and Readiness Pilot Program. Collaborations between industry and regulators are key to bringing innovative technologies to market while ensuring a science-based regulatory framework to assure consistent product quality.