Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions, in the U.S. and Europe, respectively, are key milestones in drug development that mark the transition from bench research to first-in-human trials. Understanding the nuances of each and the differences between them is a crucial step in setting the drug sponsor up for success on the path to commercialization.
In this guide, we outline the primary purpose and main components of both IND and CTA submissions, compare the essential contents of each, and highlight the key process differences to be aware of between the two.
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