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US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) (2004) Guidance for Industry. Botanical Drug Products.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation
/Guidances/ucm070491.pdf http://dx.doi.org/10.1002/jmv.23411

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