AABB launches toolkit to support members in midst of new FDA guidance

In response to new Food and Drug Administration recommendations (FDA), AABB launched a new toolkit, “AABB Resources to Support Implementation of FDA’s Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) and Sepsis by HCT/Ps.” 

The toolkit is to support members as they begin applying these guidelines: “Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” and “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).”

According to AABB, “FDA issued these guidances ‘without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (see 21 CFR 10.115(g)(2)).’” AABB’s new resource aims to help further explain FDA’s guidances and provides members with things they “may consider when developing protocols to meet the HCT/P donor eligibility recommendations of the final guidance documents.”

AABB release