Drug and biologic product submissions that include a medical device constituent parts are required to include information supporting the safety and efficacy of those constituents within investigational, original, and supplemental drug and biologic applications. Expectations for chemistry, manufacturing, and control (CMC) information submitted within investigational and marketing applications have been long established through resources such as ICH M4Q and Q12 for drug substances and drug products. However, these submission principles have not been consistently applied to medical device constituent parts. This session will cover state-of-the-art submission approaches for CMC content in drug and biologic applications and explore opportunities to align these approaches to the submission of medical device information.