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Human tissue screening draft guidance should be converted into a rule -- Red Cross.

This article was originally published in The Gray Sheet

Executive Summary

PROCESSED HUMAN TISSUE FDA DRAFT GUIDANCE SHOULD UNDERGO FORMAL RULEMAKING, the American Red Cross says in July 20 comments on FDA's recent draft document on screening and donor testing of banked human tissue. "Adopting the requirements [of the guidance] as a rule will avoid confusion as to its applicability and reduce the potential for later legal challenge," ARC states.

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