# 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of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-to-reduce-the-risk-of-transmission-of-disease-agents-associated-with-sepsis-by-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-draft-guidance-for-industry/eaa9076d-b6ed-4e0a-a30f-6eaf0e512040

> FDA guidance document: 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of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry. Issue date: May 02, 2025. Get complete insights and analysis.

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## Details

- Title: 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of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2025-05-02
- Comment Close Date: 2025-07-07
- Last Changed: 2025-05-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-3067">FDA-2024-D-3067</a>

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