The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: M4Q: The CTD - Quality


Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; ;

Document Type:
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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