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GUIDANCE DOCUMENT

Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs Guidance for Industry June 2007

Final
Docket Number:
2006D-0108
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2006D-0108.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010