US Health Leaders Urge Smarter Oversight for Cell and Gene Therapies

Published on HHS (LinkedIn)

At a recent roundtable on cell and gene therapies, Health Secretary Robert F. Kennedy Jr., FDA Commissioner Martin Makary, NIH Director Jay Bhattacharya, and CMS Administrator Mehmet Oz outlined the need for a more adaptive regulatory approach. The panel acknowledged the promise of these therapies while pointing to outdated policies that may be limiting access and innovation. Stakeholders were invited to propose which rules should be removed or revised. Topics included new trial designs, flexible approval pathways, and global competitiveness, all framed around keeping patients safe while accelerating breakthroughs.

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👉 After this week’s cell and gene therapy roundtable at FDA...

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