FDA Modernization Act 2.0: transitioning beyond animal models with human cells, organoids, and AI/ML-based approaches

J Clin Invest. 2023 Nov 1;133(21):e175824. doi: 10.1172/JCI175824.

Authors

Peter-James H Zushin^{1

2}, Souhrid Mukherjee³, Joseph C Wu^{1

2

3}

Affiliations

¹ Stanford Cardiovascular Institute and.
² Department of Medicine (Division of Cardiology), Stanford University, Stanford, California, USA.
³ Greenstone Biosciences, Palo Alto, California, USA.

No abstract available

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Animals
Drug Approval*
Humans
Models, Animal
Organoids*
United States
United States Food and Drug Administration

Grants and funding