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Streamlining Pancreatic Islet Cell Transplantation for Diabetes Patients.

This Act changes how pancreatic islet cells, harvested from deceased donors and used to treat diabetes, are regulated. Instead of being classified as drugs or biological products, they will be regulated as organs for transplantation. This aims to simplify procedures and potentially increase the availability of this life-saving therapy for patients with severe Type 1 diabetes.
Key points
Pancreatic islet cells (used for diabetes treatment) are now legally treated as organs, not drugs or biological products.
This change is intended to speed up and simplify access to these cell transplants for patients by bypassing lengthy drug approval processes.
The Secretary of Health and Human Services must update regulations within one year to implement this new classification.
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Additional Information
Print number: 118_S_2205
Sponsor: Sen. Lee, Mike [R-UT]
Process start date: 2023-06-22