 The U.S. Food and Drug Administration's Stakeholder Engagement Staff invites you to an important stakeholder call on the recently released blood donation draft guidance on Tuesday, January 31, 2023, at 11:00 am ET.
Panelists will include Admiral Rachel L. Levine, Assistant Secretary for Health for the U.S. Department of Health and Human Services; Dr. Peter Marks, Director, Center for Biologics Evaluation and Research and Harold J. Phillips, Director, White House Office of National AIDS Policy.
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Meeting ID: 161 864 4003
FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply
The U.S. Food and Drug Administration today announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.
These draft recommendations are based on the FDA’s careful review of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply.
“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
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