E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting
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.
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)
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