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

Issue Date: June 1, 2007
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

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

This guidance provides recommendations to you, a blood establishment, for obtaining written informed consent from a prospective Source Plasma donor participating in a plasmapheresis program or an immunization program. In this guidance, we, FDA, provide recommendations on how to satisfy the requirements for informed consent under 21 Code of Federal Regulations (CFR) 640.61─Informed consent, as they relate to plasmapheresis and immunization programs.This guidance is intended to assist you in planning and applying for your original Biologics License Application (BLA) or in supplementing your existing BLA regarding your informed consent procedures and documents.

Download the Guidance Document