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GUIDANCE DOCUMENT

E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting September 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2003-D-0371
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

It is important to establish an internationally standardized procedure in order to improve the quality of post-approval safety information and to harmonise the way to gather and report information. ICH E2A provides guidance on pre-approval safety data management. Although many stakeholders have applied these E2A concepts to the post-approval phase, there is a need to provide further guidance on the definitions and standards for post-approval expedited reporting. This guideline is based on the content of ICH E2A with consideration as to how the terms and definitions can be applied in the post-approval phase of the product life cycle.

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All written comments should be identified with this document's docket number: FDA-2003-D-0371.

 
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