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Evaluating the potential for digital submission of expedited premarket safety reports to the FDA

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Figure 1: General workflow and technical configuration of the second stage of the FDA's premarket safety reports pilot programme.

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Authors and Affiliations

  1. Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Avenue, Silver Spring, 20993, Maryland, USA

    Sean Khozin, Meredith Chuk, Tamy Kim, Geoffrey Kim & Richard Pazdur

  2. Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, 20993, Maryland, USA

    Suranjan De & Sanjay Sahoo

Authors
  1. Sean Khozin
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  2. Meredith Chuk
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  3. Tamy Kim
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  4. Suranjan De
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  5. Sanjay Sahoo
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  6. Geoffrey Kim
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  7. Richard Pazdur
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Corresponding author

Correspondence to Sean Khozin.

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The authors declare no competing financial interests.

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Khozin, S., Chuk, M., Kim, T. et al. Evaluating the potential for digital submission of expedited premarket safety reports to the FDA. Nat Rev Drug Discov 15, 670–671 (2016). https://doi.org/10.1038/nrd.2016.189

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  • DOI: https://doi.org/10.1038/nrd.2016.189

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