"Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection;" Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection," dated May 2005. The guidance document removes FDA's previous recommendation concerning deferral on the basis of a specific donor question related to West Nile Virus (WNV) infection. This guidance pertains solely to this specific donor deferral recommendation; all other recommendations in the "Guidance for Industry: 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 remain in effect. This guidance applies to Whole Blood and blood components intended for transfusion, and blood components intended for use in further manufacturing into injectable products or noninjectable products, including recovered plasma, Source Leukocytes and Source Plasma. This guidance has an immediate implementation date due to the approaching season during which an outbreak of WNV can occur.