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Approval times for supplemental indications for recombinant proteins

Nature Biotechnology volume 15, pages 130–134 (1997)Cite this article

Abstract

This new study shows that, in the US, approval of supplemental indications for recombinant protein products takes an average of seven months longer than approval of the original indication.

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Authors and Affiliations

  1. This work was completed at the Tifts Center for the Study of Drug Development, Tifts University, 192 South Street, Bostan, MA, 02111

    Marilyn E. Gosse & Toben F. Nelson

Authors
  1. Marilyn E. Gosse
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  2. Toben F. Nelson
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Gosse, M., Nelson, T. Approval times for supplemental indications for recombinant proteins. Nat Biotechnol 15, 130–134 (1997). https://doi.org/10.1038/nbt0297-130

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