Draft Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion" dated June 2002. The draft guidance document, when finalized, is intended to provide recommendations to blood collection or transfusion facilities on reporting fatalities related to blood or blood component collection or blood transfusion to FDA's Center for Biologics Evaluation and Research (CBER).