Proxima: “Timing is everything: Leveraging early FDA engagement to streamline development and accelerate trials.”

Navigating FDA interactions and the timing of those interactions can make or break your development timeline—and your budget. This expert panel will explore how and when to engage with FDA divisions, like CDRH, CBER, and CDER, to maximize the value of early communication. We’ll discuss key regulatory strategy touchpoints, when to involve the agency in reviewing your clinical protocol, and how early engagement can streamline both product development and clinical trial planning, reduce costly delays, and improve long-term results. Whether you’re preparing for your first IND or Q-Sub or refining your regulatory roadmap, this session will provide practical insights to help you make the most of every conversation with the FDA.

Date & Time

September 17, 2025