2024 Combo Products Summit Agenda
session
Challenges with Demonstrating Generic Substitutability for DDCs
October 9, 2024 @ 1:40 pm
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2:25 pm
Moderators
Speakers
Industry faces challenges on development and assessment of complex generic drug-device combination products (DDCPs)? How do you establish interchangeability with the RLD when you do not have visibility to their risk and design control documents? How is human factors testing useful in overcoming differences in design as compared to the RLD that may impact approvability of the generic product. This session is focused on discussing these challenges and providing regulator and industry perspective.+