Advancing PSMA Radiopharmaceuticals into the Clinic: Lessons Learned from Navigating the CDE Approval Pathway

• Sharing the development journey of a PSMA-targeted radiopharmaceutical from preclinical development through to Phase I clinical evaluation
• Exploring key considerations when preparing regulatory submissions to the Chinese CDE and identifying opportunities to accelerate clinical entry
• Understanding the similarities and differences between CDE and FDA expectations for radiopharmaceutical development
• Highlighting practical lessons learned from generating the data package required to support successful first-in-human studies and future global development

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