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BioPharmaceutical Regulation

Following Through On Breakthrough: What’s Next For FDASIA Success?

This article was originally published in RPM Report

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Executive Summary

FDA is building a case for enhanced funding to support the “Breakthrough” therapy program and at the same time is working to educate sponsors on how to use the new program effectively. The 21st Century Cures process floated a proposal for a new “Breakthrough” approval pathway – though that idea has been dropped. Still, it sets up an interesting discussion heading into 2017.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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