The goals of the workshop included the following:
Advance the science of excipient selection and regulatory evaluation.
Emphasize that regulatory science is decision science.
Recognize that better and faster decisions about excipients are needed.
Encourage innovation in product development.
Present and discuss examples of how excipients have activity, functions and side effects that impact drug product performance and equivalence.
Develop a mutual understanding of the need for expanded access to complex generics.
Subject area:
Excipients
Objectives (If applicable):
N/A
Target Audience (If applicable):