Zdrowie i gospodarka · 21/06/2007

Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs," dated June 2007. The guidance document further explains the requirements and recommendations for the informed consent of donors of Source Plasma in plasmapheresis and immunization programs. The guidance document is designed to assist blood establishments that are planning to apply for licensure or revising their existing informed consent procedures. The guidance announced in this notice finalizes the draft guidance of the same title dated April 2006. This guidance supersedes the draft guidance document entitled "Draft Reviewer's Guide: Informed Consent for Plasmapheresis/ Immunization," dated October 1995.