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FDA Modernization Act 2.0 and reproductive research

Nature Reviews Bioengineering volume 2, pages 984–986 (2024)Cite this article

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The FDA Modernization Act 2.0 allows bioengineered models in drug testing, including benchtop testing and computational models. These alternatives to animal testing may particularly advance drug discovery in reproductive and pregnancy research.

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Fig. 1: The FDA Modernization Act 2.0 presents opportunities for focusing research efforts on in vitro and in silico approaches to reproductive research.

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Acknowledgements

This paper was funded by the T32 Clinical Outcomes Research Training Program in Female Lower Urinary Tract Disorders, US National Institutes of Health grant T32DK120497 (S.G.Z.). The authors would also like to acknowledge a US National Institutes of Health T32 Postdoctoral Training Grant in Regenerative Medicine (T32EB028092) for additional research support (A.K.S.).

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA

    Samantha G. Zambuto & Michelle L. Oyen

  2. Department of Biomedical Engineering, Washington University in St. Louis, St. Louis, MO, USA

    Samantha G. Zambuto, Adrienne K. Scott & Michelle L. Oyen

  3. Center for Women’s Health Engineering, Washington University in St. Louis, St. Louis, MO, USA

    Samantha G. Zambuto, Adrienne K. Scott & Michelle L. Oyen

  4. Center for Regenerative Medicine, Washington University in St. Louis, St. Louis, MO, USA

    Adrienne K. Scott & Michelle L. Oyen

Authors
  1. Samantha G. Zambuto
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  2. Adrienne K. Scott
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  3. Michelle L. Oyen
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Contributions

S.G.Z., A.K.S. and M.L.O., conceptualization, visualization and writing (original draft, review and editing).

Corresponding author

Correspondence to Michelle L. Oyen.

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Competing interests

S.G.Z. and A.K.S. report financial support provided by the US National Institutes of Health. M.L.O. reports financial support provided by Wellcome Leap in Utero.

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Zambuto, S.G., Scott, A.K. & Oyen, M.L. FDA Modernization Act 2.0 and reproductive research. Nat Rev Bioeng 2, 984–986 (2024). https://doi.org/10.1038/s44222-024-00252-8

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