Notifying FDA of Fatalities Related to Blood Collection or Transfusion

On 20 August 2021 the FDA announced updated guidance for industry.

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). This guidance updates the guidance of the same title dated September 2003.

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