Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 1, 2017
August 22, 2019
24540605-9960-4591-9063-9a97daf273cf
Related Documents
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Specifications Document
Guidance DocumentDecember 20, 2019Center for Biologics Evaluation and Research
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for Industry
Guidance DocumentJune 14, 2023Center for Biologics Evaluation and Research
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry
Guidance DocumentMay 11, 2023Center for Biologics Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox