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GUIDANCE DOCUMENT

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting March 1995

Final
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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.