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 document entitled "Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion" dated September 2003. The guidance document provides recommendations to blood collection and transfusion facilities on reporting fatalities related to human blood and blood component collection or transfusion to FDA's Center for Biologics Evaluation and Research (CBER). The guidance announced in this notice finalizes the draft guidance of the same title dated June 2002.