Subject: Opportunity to Comment: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
From: "U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>
Date: Tue, 26 Jul 2016 11:45:23 -0500
Title: Opportunity to Comment: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
Informationabout FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
The FDA is establishing
a public docket and requesting comments, supported by scientific evidence,
regarding potential blood donor deferral policy options to reduce the risk of
human immunodeficiency virus (HIV) transmission by blood and blood products.
Specifically, the FDA
is inviting comments on the feasibility of moving from the existing time-based
deferrals related to risk behaviors to alternate deferral options, such as the
use of individual risk assessment.
The FDA is also
seeking comments regarding the design of potential studies to evaluate the
feasibility or effectiveness of such alternative deferral policy options.
The FDA will
consider comments and supporting scientific evidence received as it continues
to reevaluate and update blood donor deferral policies.
The comment period
is 120 days.
Steve Morin Office of Health and Constituent Affairs Food and Drug Administration
Richard Klein Office of Health and Constituent Affairs Food and Drug Administration
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