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GMP: FDA Guidance on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components

29.09.2016
In August 2016, the FDA published a guidance for immediate implementation on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy. After the FDA issued the Guidance for Industry \"Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture\" in spring 2015 to better ensure the safety of the nation\'s blood supply and to help protect donor health, several questions from blood establishments were submitted concerning the applicability of the donor eligibility rule to autologous donations.