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# Guide on Biologic Viral Safety Evaluations
- URL: https://www.fdaweb.com/guide-on-biologic-viral-safety-evaluations/
- Published: 2024-01-12T12:00:00.000Z
- Updated: 2026-09-14T14:20:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156133

*Federal Register* notice: FDA is making available a final guidance entitled “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.” The International Council for Harmonization document is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-01-11/pdf/2024-00407.pdf?ref=fdaweb.com).