Breakthrough-Therapy Designation — An FDA Perspective

  • Corrigan-Curay J
  • McKee A
  • Stein P
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Abstract

Breakthrough-Therapy Designation The authors provide a perspective on the rationale and goals of the designation of “breakthrough therapy” by the Food and Drug Administration.

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Corrigan-Curay, J., McKee, A. E., & Stein, P. (2018). Breakthrough-Therapy Designation — An FDA Perspective. New England Journal of Medicine, 378(15), 1457–1458. https://doi.org/10.1056/nejmc1801222

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