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FDA Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma

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
Content:
This guidance recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 1.0.1 dated December 2010, prepared by the Plasma Protein Therapeutics Association (PPTA) as an acceptable mechanism that is consistent with the Food and Drug Administration’s (FDA’s) requirements and recommendations for collecting Source Plasma donor history information.

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