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American Focus > Blog > Health and Wellness > FDA hints relaxed rules are coming for rare disease gene therapy
Health and Wellness

FDA hints relaxed rules are coming for rare disease gene therapy

Last updated: June 6, 2025 11:05 am
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FDA hints relaxed rules are coming for rare disease gene therapy
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The Trump administration’s impact on gene therapy was a topic of discussion at a recent FDA “Cell and Gene Therapy Roundtable.” The event brought together researchers, advocates, and industry executives to share their insights on the future of gene therapy under the new administration.

Despite the lack of a clear agenda, panelists were asked to provide their perspectives on what the FDA should know about cell and gene therapy. This led to a two-hour discussion where participants shared their thoughts and concerns about the regulatory landscape and potential challenges facing the field.

Health secretary Robert F. Kennedy Jr., NIH Director Jay Bhattacharya, and CMS Administrator Mehmet Oz also made statements during the event. However, due to time constraints, the discussion was cut short, leaving many unanswered questions about the future of gene therapy regulation and access.

The exclusive details of the roundtable discussion are available to STAT+ subscribers, offering in-depth coverage and analysis of the biotech sector. To access the full article and stay informed about the latest developments in gene therapy, consider subscribing to STAT+.

Overall, the FDA roundtable provided a glimpse into the potential impact of the Trump administration on gene therapy. With ongoing discussions and debates surrounding regulatory policies and patient access, the future of gene therapy remains uncertain. Stay tuned for more updates on this evolving field.

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TAGGED:ComingdiseaseFDAgenehintsRarerelaxedrulesTherapy
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