Zdrowie i gospodarka · 3.07.2003
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self- Administered Questionnaires" dated July 2003. The guidance document provides guidance to blood and plasma establishments on the recommendations of FDA for implementing self-administered donor questionnaires at the predonation donor screening interview. The guidance document also describes the information to be included in a biologics license application supplement or annual report for the implemented changes. The guidance supersedes section I.A of FDA's memorandum dated April 23, 1992, entitled "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," and finalizes the draft guidance of the same title dated April 2002.