Guidance On Donor Suitability/Safety in SARS Cases
04/23/2003
Federal Register Notice: FDA is making available 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. The guidance document provides agency recommendations for assessing donor suitability and blood product safety with respect to SARS and 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. To download the guidance, click here. To view this notice, click here.