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2. U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320.25(a), Office of Federal Register, National Archives and Records Administration (2007).
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4. U.S. Food and Drug Administration, Title 21 Code of Federal Regulations (CFR) Part 320, Office of Federal Register, National Archives and Records Administration (2006).
5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance Documents, accessed on March 3, 2008. http://www.fda.gov/cder/guidance/index.htm