REGULATORY UPDATE: AABB, ABC and ARC Submit Joint Comments to FDA on Mtb and Sepsis Draft Guidances

AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) recently submitted two sets of joint comments to the Food and Drug Administration in response to draft guidance documents addressing the transmission risk of Mycobacterium tuberculosis (Mtb) and sepsis by human cell, tissues and cellular and tissue-based products (HCTPs). FDA initially published the guidances as final in January but later withdrew and reissued them as draft guidances “with revisions in response to comments FDA received.”

The joint comments remain largely consistent with the previous comments. The blood community’s comments 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.”

Member centers may contact regulatory@aabb.org with questions.