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FDA: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability

Source
Federal Register
Link
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Date
Jan 30, 2023
Summary
Notice from the Food and Drug Administration (FDA) seeking comment on revised draft guidance titled "Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry." The draft guidance provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. The FDA now recommends assessing donor eligibility using gender-inclusive, individual risk-based questions relevant to HIV risk. Comments are due by March 31, 2023.
Tagged as
HIV and AIDS · Healthcare quality · Legislation and regulations · Policy · Sexual and reproductive health