FDA Releases Draft Guidance on Reducing Risk of Creutzfeldt-Jakob Disease Transmission from Human Cells and Tissues

Summary

The FDA has made available a draft document outlining steps to minimize the risk of Creutzfeldt-Jakob Disease (CJD) and Variant CJD (vCJD) transmission through human cellular and tissue-based products (HCT/Ps), and is seeking comments on the guidance, which includes recommendations for donor screening and study data on the impact of these measures on the HCT/P supply.