Abstract
In July 2012, the FDA Safety and Innovation Act created the “breakthrough therapy” designation to expedite development of therapies for serious diseases when evidence suggests substantial superiori...
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CITATION STYLE
APA
Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2014). New FDA Breakthrough-Drug Category — Implications for Patients. New England Journal of Medicine, 370(13), 1252–1258. https://doi.org/10.1056/nejmhle1311493
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