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FDA 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of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts DRAFT GUIDANCE

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry DRAFT
Content:
This document informed all registered blood and plasma establishments, and establishments engaged in manufacturing plasma derivatives, of the Food and Drug Administration's (FDA) recommendations to indefinitely defer xenotransplantation product recipients and their intimate contacts from donating blood or plasma. This document also contains 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.

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