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

摘要

This guidance recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 1.2 dated September 2012, 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. In the future, we, FDA, may recognize other Source Plasma donor history questionnaires and accompanying materials as acceptable. We intend to make the current recognized versions of the Source Plasma donor history questionnaires and accompanying materials (referred to as SPDHQ documents) available on the FDA website.