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2024 Combo Products Summit Agenda


Aligning Device Constituent Parts With Drug CMC Review Principles

October 9, 2024 @ 11:25 am


12:25 pm


Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca
Rumi Young, Director, Regulatory Policy, Novo Nordisk


Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA 
Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

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.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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