Challenges with Demonstrating Generic Substitutability for DDCs

2024 Combo Products Summit Agenda

session

Challenges with Demonstrating Generic Substitutability for DDCs

October 9, 2024 @ 1:40 pm

2:25 pm

Moderator

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 Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), FDA

Chirag Walawalkar, Director, Device Design & Process Development, Merck

Industry faces challenges on development and assessment of complex generic drug-device combination products (DDCPs). How do you establish interchangeability with the reference listed drug (RLD) when you do not have visibility to its risk and design control documents? How is human factors testing useful in overcoming differences in design as compared with the RLD, which may impact approvability of the generic product? This session is focused on discussing these challenges and providing regulator 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.

2024 Combo Products Summit Agenda

session