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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2003-D-0371.