Post-approval evidence generation is essential for high-quality clinical care and should be a shared priority for clinicians, health systems, payors, and the medical products industry, as well as the FDA and federal agencies.
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The authors acknowledge J. Woodcock, P. Marks and P. Stein for their comments on this manuscript.
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A.A. is a resident physician at the University of California, San Francisco, is the recipient of an NIH T32 training grant (5T32CA251070-04) on assignment at the US Food and Drug Administration (FDA) and has no conflicts of interest related to this manuscript to disclose; he reports past consulting income from LeMaitre and MIS Technologies, LLC. D.R. is an employee of the FDA and has no conflicts of interest to report. L.H.C. is a faculty member at Duke University who is on assignment at the FDA and has no conflicts of interest related to this manuscript to disclose; she reports past consulting income from Regeneron Pharmaceuticals, the NFL Players Association and Boehringer Ingelheim and institutional grants from GlaxoSmithKline and Novartis. R.M.C. is an employee of the FDA and has no conflicts of interest related to this manuscript to disclose; prior to his appointment to the FDA as Commissioner for Food and Drugs, he was an employee of and held equity in Verily Life Sciences and Google Health (Alphabet) and served on boards of directors for Cytokinetics, Centessa, Clinetic, Keystone Symposia, the Critical Path Institute (C-Path), the Clinical Research Forum and One Fifteen.
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Abbasi, A., Rivera, D., Curtis, L.H. et al. Post-approval evidence generation: a shared responsibility for healthcare. Nat Med (2024). https://doi.org/10.1038/s41591-024-03241-x
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DOI: https://doi.org/10.1038/s41591-024-03241-x
