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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1993-D-0128.

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