Zdrowie i gospodarka · 22.04.2002
Draft “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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires" dated April 2002. The draft document, when finalized, is intended to provide guidance to blood and plasma collection centers on the recommendations of FDA for implementing self-administered donor questionnaires at the predonation donor screening interview. The draft guidance document also describes the information to be included in a biologics license application supplement or annual report for the implemented changes.