Blood community comments on FDA’s Mtb and sepsis draft guidances

July 8, 2025

According to an announcement, AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) responded to the Food and Drug Administration’s draft guidances on the transmission risk of Mycobacterium tuberculosis (Mtb) and sepsis by human cell, tissues and cellular and tissue-based products (HCTPs). 

The organizations released joint comments that “include a request for clarification and a definition of “frequently traveled to areas of the world where TB is common” and a request for additional considerations for the collection of cellular starting material from “healthy donors.”’ 

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