E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

Docket Number:: FDA-1993-D-0128
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

It is important to harmonize the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development.

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E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

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