Zdrowie i gospodarka · 07/02/2001

Draft “Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans;” Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans" dated February 2001. The draft guidance document is intended to provide guidance on the production, testing, and evaluation of products intended for use in xenotransplantation.