← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEMay 5, 2025NOTICE — NO LEGAL EFFECT

Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability

What this record is not

Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEJul 7, 2025 · closed
APPLIES TO · SPEQ TAGBiologics
Document type
Notice
Agency
Health and Human Services Department
Published
May 5, 2025
Comments close
July 7, 2025
Document number
2025-07752
Docket
FDA-2024-D-3067, FDA-2024-D-3863
ABSTRACT

The Food and Drug Administration (FDA or the Agency) is withdrawing two final guidances entitled "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)" and "Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and reissuing them as draft guidances.

Abstract as published in the Federal Register.