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FDA Guidance for Industry

FDA Guidance for Industry - Use of Donor Screening Test to Test Donors of Human Cells, Tissues and Cellular and Tissue - Based Products for Infection with Treponema pallidum ​(Syphilis).

This email is to alert you that the availability of a guidance from the FDA, "FDA Guidance for Industry - Use of Donor Screening Test to Test Donors of Human Cells, Tissues and Cellular and Tissue - Based Products for Infection with Treponema pallidum ​(Syphilis)" was published in the September 9, 2015, Federal Register. The text of the guidance may be found by clicking here. View/download the Federal Register notice here. 

This guidance is currently open for public comment. Entities involved in the manipulation of HCT/Ps should read the guidance and determine for themselves the applicability of the guidance to their programs.