"Validation checks" is an intimidating phrase, but the FDA's intent here is to ensure that your submission is accurately and timely routed. More information about FDA's validation checks may be found online. Select each link below to view a PDF of the relevant guidance.
| Document | Description |
|---|---|
| Guidance for Industry Providing Regulatory Submissions in Electronic Format – Receipt Date | This document provides guidance about how the FDA determines the receipt date of submissions provided in electronic format. |
| Specifications for eCTD Validation Criteria | This document details the validation criteria applied when FDA processes eCTD submissions. The document is located in the eCTD Submission Standards (under Quick Links on www.fda.gov/ectd). |
How can we apply this guidance to keep your submission from being rejected?
