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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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires" dated April 2002.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 The draft guidance document also describes the information to be included in a biologics license application supplement or annual report for the implemented changes.

Source: Federal Register — Food and Drug AdministrationOpen original release →