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# Guide on Biotech Product Viral Safety Evaluations
- URL: https://www.fdaweb.com/guide-on-biotech-product-viral-safety-evaluations/
- Published: 2022-11-14T12:00:00.000Z
- Updated: 2026-09-14T18:06:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153193

*Federal Register* notice: FDA has made available a draft guidance entitled “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin.” The International Council for Harmonization describes 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-2022-11-14/pdf/2022-24685.pdf?ref=fdaweb.com).