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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:
To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.
- Engaging with the FDA on a peer-to-peer level
- Effectively negotiating about innovative approaches that may be outside of guidelines
- How to react and respond to feedback and questions from the FDA
To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.
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By Conference ForumThis 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:
To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.
- Engaging with the FDA on a peer-to-peer level
- Effectively negotiating about innovative approaches that may be outside of guidelines
- How to react and respond to feedback and questions from the FDA
To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.