FDA Brief: Week of Mar 14, 2016
Guidance : 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