MAGI
Talk Quality / Regulatory track
I Wish I Had a Crystal Ball: Approaches to IND Submissions for IITs
Tue, May 20, 2025 · 2:00–3:30 PM EDT Sheraton Boston Hotel
About this session
This session will focus on factors that influence decision-making on whether to submit Investigator Initiated projects to the FDA for evaluation. The presentation will include a few case studies illustrating when we were surprised the FDA exempted something, or required an IND when we were fairly sure it wouldn't; and how each experience further informs our approach to making the decision to submit to FDA or not.
