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Zdrowie i gospodarka · 27.04.2006

Draft “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 draft document entitled "Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs," dated April 2006. The draft guidance document further explains the requirements on informed consent as they relate to plasmapheresis and immunization programs. The draft guidance document is designed to assist blood establishments planning to apply for licensure or those revising their existing informed consent forms in determining whether the documents include all the appropriate information. This draft guidance, when finalized, will supersede the draft guidance document entitled "Draft Reviewer's Guide: Informed Consent for Plasmapheresis/Immunization," dated October 1995.

Source: Federal Register — Food and Drug AdministrationOpen original release →