The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

@article{Wallach2018TheUF,
  title={The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.},
  author={Joshua D Wallach and Joseph S Ross and Huseyin Naci},
  journal={Clinical trials},
  year={2018},
  volume={15 3},
  pages={
          219-229
        }
}
The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved… CONTINUE READING

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