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FDA Guidance for Industry: M4Q: The CTD - Quality

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

Document Type:
Guidance
Content:
This guidance addresses the organization of the information to be presented in the Quality section of an application for new pharmaceuticals (including biotechnology-derived products).

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