FDA Guidance for Industry: M4S: The CTD - Safety

Titel:
FDA Guidance for Industry: M4S: The CTD - Safety
Herkunft/Verlag:

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/ucm073299.pdf

Dokumentenart:
Guidance
Inhalt:
This guidance presents the format for the preparation of a well-structured Safety section of the CTD for applications that will be submitted to regulatory authorities.

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