"Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS;" Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS" dated April 2003. The guidance document provides our recommendations for assessing donor suitability and blood product safety with respect to SARS. The guidance applies to whole blood and blood components intended for transfusion and to blood components including recovered plasma, source leukocytes, and source plasma intended for use in further manufacturing into injectable or noninjectable products.