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2024 Combo Products Summit Agenda

session

Challenges of Complex Generic DDCP Development and Assessment

October 9, 2024 @ 1:40 pm

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2:25 pm

Moderators

Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Eli Lilly

Speakers

Brian Neely, Chemist, Center for Drug Evaluation and Research (CDER), FDA 
Andrew Fine, Senior Advisor in Division of Clinical Review in OGD, Center for Drug Evaluation and Research (CDER), FDA
Chirag Walawalkar, Director Device Design & Process Development, Merck (Invited)

Industry faces challenges on development and assessment of complex generic drug-device combination products (DDCPs). When is it critical for a generic to be identical to an RLD? When is human factors testing useful in overcoming differences that may not impact safety or usability of the product? This session is focused on discussing these challenges and providing regulatory and industry perspective.

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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© 2024 AFDO/RAPS Healthcare Products Collaborative