FDA & Health Authority Fireside Chat
November 30 @ 1:40 pm – 3:10 pm
What is at the top of your mind regarding combination products? Join our FDA Fireside Chat to address your questions! In a world of uncertainty as it relates to combination product development, quality systems readiness, product approval, post-market requirements, evolving regulations and expectations, our FDA panel will address your questions anonymously or in real time in an informal, collaborative setting to get to the heart of your most pressing challenges. Don’t miss the opportunity to engage with FDA to hear their comments during the 2023 Combination Products Summit Fireside Chat!
We want to hear from you!
Submit your non-confidential questions hereAll submitted questions will be compiled and asked anonymously of the FDA during the Summit. Questions will also be collected throughout the Summit, and there will be an opportunity to ask questions real-time as well.
Moderators
- Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC
- Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
Speakers
- Thinh Nguyen, Director, Office of Clinical Policy & Programs
- James Bertram, Director, Office of Combination Products
- John “Barr” Weiner, Associate Director for Policy, Office of Combination Products