• 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...
  • Regulatory NewsRegulatory News

    FDA Clarifies Syphilis Screening Procedures for Blood, Plasma Donations

    • 28 August 2014
    A new guidance document issued by the US Food and Drug Administration (FDA) finalizes an earlier draft set of recommendations on how blood and plasma collection centers can screen donors and samples for syphilis. Background Blood and plasma donations, like the donation of all cell and tissue products, are already subject to a battery of tests to ensure they are not contaminated with any serious diseases. At present, those tests include ones to detect hepatitis B and C, ...