• Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Donor Screening for Syphilis Infection

    The US Food and Drug Administration (FDA) has finalized its guidance to establishments that screen human tissue and cell donors for various communicable diseases on screening for Treponema pallidum , commonly known as syphilis. Background Under 21 CFR 1271.80 , establishments that screen donors of human cells, tissues and cellular and tissue-based products (HCT/P establishments) are required to screen for specific diseases, such as syphilis, human immunodeficiency vi...