Enhanced Strategic FDA Collaboration: Working with CDER and CBER

This podcast features a panel discussion from the 2025 Chief Medical Officer Summit 360° with biotech CMOs across indications about how CMOs can best support their regulatory teams and engage with the FDA and other regulators. Specifically, the panelists address:Engaging with the FDA on a peer-to-peer levelEffectively negotiating about innovative approaches that may be outside of guidelinesHow to react and respond to feedback and questions from the FDATo learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.