The HCT/P Modernization Act of 2025
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
The HCT/P Modernization Act of 2025 directs the Food and Drug Administration (FDA) to improve the regulation of human cell and tissue products (HCT/Ps). The bill mandates the FDA to provide educational resources, publish data on manufacturing and inspection activities, and conduct workshops to engage stakeholders. It also requires the FDA to submit a report to Congress with recommendations for modernizing HCT/P regulation, considering factors like regulatory burden and scientific advancements.
Key provisions
- Publish educational materials about the Tissue Reference Group and best practices for obtaining recommendations.
- Annually publish data on registered HCT/P establishments, inspections conducted, inquiries to the Tissue Reference Group, and average response times.
- Conduct workshops and educational sessions for stakeholders including industry, researchers, and patients.
- Establish a public docket to receive comments on modernizing HCT/P regulation.
- Submit a report to Congress with recommendations for regulating HCT/Ps by September 30, 2026.
- Amend the Food and Drug Omnibus Reform Act of 2022 to prioritize scientific data for cellular therapies.
Who is affected
- Food and Drug Administration (FDA)
- Human cell and tissue manufacturers
- Biomedical researchers
- Healthcare providers
- Patients
Notable changes
Bill text
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