Regulatory updates are needed to prevent the commercialization of islet transplantation in the United States

We are writing with great concern about the consequences of applying drug related regulations to allogeneic islets (allo-islets). Currently, the Food and Drugs Administration (FDA) is reviewing a Biologics License Application (BLA) for the isolation of allogenic islets which, if approved, will effectively confer marketing rights to a private, for-profit company.1.