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: