The agencysaid in a news releasethat blood donor eligibility will now be determined using a set of "individual, risk-based questions to reduce the risk of transfusion-transmitted HIV." The recommendations, first proposed in January, ask that all donors answer individual risk assessment questions to...
The US Food and Drug Administration (FDA) has announced proposedchanges in its recommendationsgoverning blood donor eligibility to reduce the risk of transfusion-transmitted HIV. The proposed guidance assesses risk using gender-inclusive, individual questionnaires rather than using broad time-based...
Medical News in Brief The US Food and Drug Administration (FDA) has announced proposed changes in its recommendations governing blood donor eligibility to reduce the risk of transfusion-transmitted HIV.Harris, EmilyJAMA: Journal of the American Medical Association...
After decades of rejecting or discouraging men who have sex with men (MSM) from donating blood for fear of HIV transmission, the FDA issued final guidanceopens in a new tab or window on Thursday relaxing donor eligibility rules. Under the new recommendations, the FDA scrapped time-based deferra...
(1)Criteria used to determine donor eligibility, including acceptable medical history criteria. (1)用于确定供体资格的标准,包括可接受的病史标准。 (2) Methods of performing donor qualifying tests and measurements, including minimum and maximum values for a test or procedure when a factor in determining...
The collection, processing, compatibility testing, storage and distribution of human blood and blood components must be performed in accordance with applicable requirements for current good manufacturing practices and must be collected in accordance with applicable requirements for donor eligibility and donatio...
Currently, federal regulations prohibit blood banks from accepting donations from men who have had sex with men within the last three months. In a recent FDA-funded donor eligibility study, using blood surveillance information, the FDA says it will most likely support a policy transiti...
"Based on recently completed studies and epidemiologic data, the FDA has concluded that current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply," it said. "These changes are being put forth for immediate implementation and are ...
• Blood Pressure and Pulse Donor Eligibility Requirements; Compliance Policy; Guidance for Industry 指南题目:血压和脉搏供体资质要求。 血液制品生产离不开血浆;而对于供者的身体素质监控,既是为了保证供者健康,也是为了确保血浆质量。因此FDA...
In support of this new 2020 revision of its blood donation restrictions, the FDA stated that based on recent studies, the agency found that current policies addressing donor eligibility can be modified without compromising the safety of the blood supply. The FDA stated that the recommendati...