# Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/source-animal-product-preclinical-and-clinical-issues-concerning-the-use-of-xenotransplantation-products-in-humans-guidance-for-industry/38608057-6efd-4c37-9075-3043bba2c602

> FDA guidance document: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans:  Guidance for Industry. Issue date: December 13, 2016. Get complete insights and analysis.

---

## Details

- Title: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans:  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: 2016-12-13
- Last Changed: 2024-04-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2000-D-0129">FDA-2000-D-0129</a>

## Related Documents

- [Considerations for the Development of Dried Plasma Products Intended for Transfusion:   Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-development-of-dried-plasma-products-intended-for-transfusion-guidance-for-industry/c0c693ab-7392-4bad-b4c9-de122a24ced4)
- [Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-nucleic-acid-tests-to-reduce-the-risk-of-transmission-of-hepatitis-b-virus-from-donors-of-human-cells-tissues-and-cellular-and-tissue-based-products-guidance-for-industry/ff060472-0a8c-471b-b947-33ce77342401)
- [Recommendations for Microbial Vectors Used for Gene Therapy:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-microbial-vectors-used-for-gene-therapy-guidance-for-industry/bdeabfdf-bbbe-4b57-a5be-ef92ff0cf1bd)
