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Supporting a data-driven approach to regulatory intelligence

Drug developers are increasingly applying data-driven analysis of the actions of regulatory agencies to gain insights into their expectations and applications of regulatory policy, but such strategies can be limited by the availability and quality of regulatory datasets. Here, we discuss how establishing a single, robust, accessible database of FDA regulatory actions could help address this limitation.
  1. Andrew S. Robertson

    1. Sanofi, Cambridge, MA, USA.

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  2. Alexis Reisin Miller

    1. Sanofi, Cambridge MA, USA.

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  3. Felipe Dolz

    1. Sanofi, Cambridge MA, USA.

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Drug developers need to understand and anticipate the actions of regulatory agencies such as the FDA and EMA to develop drugs efficiently and effectively. To achieve this, they have traditionally used ‘regulatory intelligence’ approaches, which include reviewing regulatory guidance documents, tracking recent regulatory decisions and directly consulting former regulators.

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Nature Reviews Drug Discovery 20, 161-162 (2021)

doi: https://doi.org/10.1038/d41573-020-00101-4

Acknowledgements

The authors thank C. Kieffer, B. Sickels, E. Reilly, and H. Malone for their contributions and perspectives on this topic.

Updates & Corrections

  • Correction 01 June 2020: The spelling of Alexis Reisin Miller's name has been corrected.

References

  1. Kieffer, C. M. et al. FDA reported use of patient experience data in 2018 drug approvals. Ther. Innov. Reg. Sci. https://doi.org/10.1177/2168479019871519 (2019).

  2. Kieffer, C. M., Robertson, A. S. Impact of FDA-required cardiovascular outcome trials on type 2 diabetes clinical study initiation from 2008 to 2017. Ther. Innov. Reg. Sci. https://doi.org/10.1177/2168479019860122 (2019).

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  5. Audibert, C. et al. Building a drug development database: challenges in reliable data availability. Drug. Dev. Ind. Pharm. https://doi.org/10.1080/03639045.2016.1220565 (2017).

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Competing Interests

The authors are all employed by Sanofi, a biopharmaceutical company engaged in drug and vaccine development and manufacturing.

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