Critique of FDA Draft Rules for Good Tissue Practices

The American Society for Blood and Marrow Transplantation (ASBMT) and the Foundation for Accreditation of Hematopoietic Cell Therapy (FAHCT) have submitted comments to the U.S. Food and Drug Administration, raising concerns about specific requirements in proposed new rules for "good tissue practices."

The draft rules are the concluding phase of a 1997 FDA initiative addressing safety and product quality. They address methods, facilities and controls in the "manufacture" of human cellular and tissue-based products. They include labeling requirements, reporting of product deviations and adverse reactions, and FDA inspections to enforce compliance. Certain cellular and tissue-based products that require licensing or pre-market approval as biological products or medical devices would be subject to new additional requirements.

Although most of the elements in the draft regulations conform to voluntary standards already adopted by FAHCT, certain components are differences and discrepancies that could have a negative impact on blood and marrow transplantation, according to both statements.

To read the full text of the submitted documents, click on one of the links below:

ASBMT Critique of FDA Draft Rules

FAHCT Critique of FDA Draft Rules

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