A guide to successful regulatory engagements
Gain invaluable insights into the FDA interaction process for early-stage biotechs developing therapeutic or medicinal products.
This webinar will cover crucial topics such as when to approach the FDA, available meeting types, expected responses, data package requirements for an FDA IND request, and the significance of a well-crafted regulatory strategy.
Presented by Zeb Younes, Head of Product Development & Regulatory Consulting, Principal Consultant; and Dan Cafaro, Principal Consultant at SCENDEA.