FDA Releases Draft Guidance on Reporting Fatalities Related to Blood Collection or Transfusion

Summary

The Food and Drug Administration (FDA) has released a draft guidance document outlining the process for notifying the agency of fatalities related to blood collection or transfusion, with the goal of improving reporting to the Center for Biologics Evaluation and Research (CBER). The draft guidance, dated June 2002, aims to provide recommendations for blood collection or transfusion facilities on reporting such fatalities to the FDA.