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eCTD Validation Specifications
Validation is an important processing component in order to ensure compliance with the eCTD specification and improve the availability and reviewability of individual submissions and applications throughout their lifecycle. To facilitate the publication of guidance and specification compliant submissions, FDA is making available its current Validation Specifications
Specifications for eCTD Validation Criteria [PDF]  (3/10/2008)
In addition to the validation criteria specified in this document, FDA may perform additional validation checks for both eCTD and non-eCTD submissions. These validation checks are intended to ensure that submissions are processed and routed accurately and in a timely fashion. The additional validation checks include:
- Ensuring that the application form submitted matches the application type specified in the us‑regional.xml file, e.g., the us‑regional.xml specified application type is NDA but the sponsor has submitted a 1571.
- Ensuring the consistency of the application number specified in the us‑regional.xml file and application form.
Additional information on submissions that do not pass the Agency’s validation checks may be found in Guidance for Industry Providing Regulatory Submissions in Electronic Format — Receipt Date [PDF] (Draft 6/4/2007)
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Date created: March 12, 2008 |
