Draft “Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Intimate Contacts;” Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Intimate Contacts" dated February 2002. The draft guidance document provides recommendations to all registered blood and plasma establishments, and establishments engaged in manufacturing plasma derivatives. The draft guidance document, when finalized, is intended to provide recommendations regarding the disposition of blood products manufactured from a donor who is retrospectively discovered to have received a xenotransplantation product or to have been an intimate contact of a xenotransplantation product recipient. This is the second draft guidance document and it incorporates revisions based on public comments received on the first draft guidance document by the same name announced in the Federal Register of December 30, 1999 (64 FR 73562).