Draft “Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;” Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection," dated April 2005. The draft guidance document provides revisions to the previously published recommendations for assessing donor suitability and product safety when donors are diagnosed with or suspected of West Nile Virus (WNV) infections based on symptoms and laboratory tests. This draft guidance proposes revised deferral periods for such donors, and updates information on product retrieval and quarantine. When finalized, this guidance will supersede "Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection," dated May 2003.