Health Affairs January 23, 2026
Holly Fernandez Lynch, Reshma Ramachandran, Rachel Sachs, Steven Joffe, Patricia J. Zettler

Editor’s Note

This article is the latest in the Health Affairs Forefront featured topic, “Health Policy at a Crossroads,” produced with the support of the Commonwealth Fund and the Robert Wood Johnson Foundation. Articles in this topic offer timely analysis of regulatory, legislative, and judicial developments in health policy under the Trump-Vance Administration and the 119th Congress.

In February 2025, baby KJ Muldoon was the first person to receive an investigational personalized gene-editing treatment customized to the specific genetic variant responsible for his rare genetic urea-cycle disorder. As the science of individualized therapeutics continues to progress, there are also critical regulatory and economic challenges to resolve.

In part 1 of this article, we described FDA’s broadly flexible approach to meeting...

Today's Sponsors

Venturous
ZeOmega

Today's Sponsor

Venturous

 
Topics: FDA, Govt Agencies
AI Model FDA-Cleared to Triage 14 Conditions
FDA Updates Two Digital Health Final Guidance Documents
FDA in Flux — January 2026 Newsletter
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 1)
A Relaxing 2026? FDA Updates General Wellness and Clinical Decision Support Software Guidance

Share Article