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FDA Guidance for Industry: Q3B(R) Impurities in New Drug Products
Short Title:
Q3B(R)
Origin/Publisher:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073389.pdf
Document Type:
FDA Guidance for Industry
Content:
This ICH guideline provides recommendations for the limits and the qualification of impurities to be observed for the marketing authorization of medicinal products containing new active substances.
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