IntroductionConference Proceeding - Introduction
Role of Risk Assessments in Viral Safety: An FDA Perspective
Lixin Xu, Sang Bong Lee, Chana Fuchs, Kenneth C. Hyams, Kurt Brorson and Patrick Swann
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 6-10; DOI: https://doi.org/10.5731/pdajpst.2014.00959
Lixin Xu
Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD
Sang Bong Lee
Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD
Chana Fuchs
Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD
Kenneth C. Hyams
Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD
Kurt Brorson
Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD
Patrick Swann
Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD

References
- 1.↵
ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origen. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, 1999.
- 2.↵
ICH Q9: Quality Risk Management. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, 2006.
- 3.↵
- 4.↵
- Khan A.S.,
- Lubiniecki A.,
- King K.E.
- 5.↵
- Rönninger S.,
- Holmes M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
Role of Risk Assessments in Viral Safety: An FDA Perspective
Lixin Xu, Sang Bong Lee, Chana Fuchs, Kenneth C. Hyams, Kurt Brorson, Patrick Swann
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 6-10; DOI: 10.5731/pdajpst.2014.00959
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