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FDA’s “Breakthrough” Evolves: What’s Next For The Popular Program?

This article was originally published in RPM Report

Executive Summary

FDA’s second wave of Breakthrough Therapies will look markedly different from the initial flurry of approvals. After an early focus on oncology, FDA is reviewing a more diverse set of applications in the antiviral, vaccines and cardiovascular arenas. And there will be more “breaks” during development as sponsors start to request designations based on earlier data. What will Breakthrough look like in the third year of the program?


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