FDA Guidances: Zika transmission, IND/IDE Clinical Protocol Template – Drug and Device Digest

FDA Brief: Week of Mar 14, 2016

fda guidances


zika_GzikaGuidance : To reduce risk of transfusion-tranmission of Zika Virus

  • For blood establishments that collect whole blood and blood components for donor screening, donor deferral and product management
  • Zika is an arbovirus; transmitted to humans primarily by mosquito, intrauterine, perinatal and sexual transmission have been reported
  • Risk of transmission by blood transfusion is considered likely based on case reports, viremia, pre-symptomatic periods, positive blood donation reports
  • Recommendations provided for
    • For Areas without Active Transmission
    • For Areas with Active Transmission
    • Post-Donation Information and Product Management
    • Product Disposition and Labeling


Q&A for Guidance

  • Answers to common questions from blood establishments
  • To assist blood establishments in implementing the guidance recommendations



  • Clinical Trial Protocol Template for  IND trials (drugs) or IDE trials (Devices)
  • For trials supported by the National Institutes of Health (NIH)
  • Investigators  strongly encouraged to use template; meets ICH standards
  • For Public Comment



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