FDA Engagement Strategies And Best Practices Amid Agency Changes

How can life sciences companies developing new medicines engage the FDA successfully during a period of rapid changes in agency personnel and policies? Should companies adjust their agency communication strategies or ask new questions during meetings? Panelists Jeremy Levin, DPhil, MB, BChir, Co-Founder and Executive Chairman at Ovid Therapeutics, and Annetta Beauregard, SVP, Science and Regulatory Affairs at BIO, identified the key changes happening at the FDA, shared information about how to get the most out of agency interactions, and offered tips and strategies to lower risks and avoid regulatory surprises.