Executive Summary

Unanimous approval given by the Biological Response Modifiers Advisory Committee July 30 to a report issued by the Xenotransplantation Subcommittee following its Dec. 7 meeting. At issue was the subcommittee's recommendation that FDA should allow xenotransplant clinical trials; FDA's decision to issue a guidance, due in late 1998, that may streamline clinical trials by establishing requirements for biological assays; the establishment of an electronic registry that would track recipients from transplant to death and also track donor sources; the establishment of a national xenotransplantation advisory committee to keep the public informed; and the committee's desire for worldwide harmonization of regulations governing xenotransplantation