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Recovering from an Unsatisfactory/Disastrous Pre-IND Meeting

Date: Wednesday, May 3, 2023

Speaker: Angela Drew, PhD, Vice President, Regulatory Strategy

This presentation is part of a series of webinars on 505(b)(2) NDA drug development that highlights the diversity, simplicity, and complexity of the 505(b)(2) application process. This session discusses pre-IND meetings for 505(b)(2) product development, with a focus on inadequate pre-IND examples and recovery plans for unsatisfactory meetings.

View the other webinars in the series here:

View the Webinar