Home > Journals > WMLR > Vol. 66 (2024-2025) > Iss. 6 (2025)
William & Mary Law Review
Abstract
This Note proceeds in four parts. Part I introduces AI as an emerging technology in the life sciences, the FDA’s inherited regulatory regime, and challenges under the MQD [major questions doctrine]. Part II explores how hypervigilant regulation obstructs innovation and exposes agencies to judicial challenges. Part III offers solutions to safely and effectively navigate the major questions landscape within a framework that fosters AI innovation. This Note proposes a solution that conceptually balances growth in the life sciences with the statutory elements required for a safe and effective regulatory scheme.
This abstract has been taken from the author's introduction.
Repository Citation
Hayden W. Smith, AI v. MQD: Navigating New Regulatory Challenges in the Life Sciences, 66 Wm. & Mary L. Rev. 1655 (2025), https://scholarship.law.wm.edu/wmlr/vol66/iss6/6
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