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A survey of breakthrough therapy designations

Nature Biotechnology volume 32, pages 323–330 (2014)Cite this article

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As of last month, 41 products have been granted breakthrough therapy designations by the US Food and Drug Administration—drugs against cancer, hepatitis C and monogenetic diseases predominate.

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Figure 1: Number of BTDs applied for, and number of BTDs granted and denied by CBER and CDER from July 9, 2012 to March 7, 2014.
Figure 2

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Acknowledgements

The author thanks Novel Health Strategies, the Institute for Global Policy Research, the American Society of Clinical Oncology, the American College of Rheumatology, the American Association of Liver Diseases, American Heart Association, the American Society of Hematology and the Biotechnology Industry Association for providing support for this article.

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  1. Saurabh (Rob) Aggarwal is at Novel Health Strategies LLC, Bethesda, Maryland, USA, and the Institute for Global Policy Research, Washington, DC, USA.,

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(Rob) Aggarwal, S. A survey of breakthrough therapy designations. Nat Biotechnol 32, 323–330 (2014). https://doi.org/10.1038/nbt.2864

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