Latest FDA eCTD Validation Criteria Draft Guidance Adds, Removes Error Conditions

The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.

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How to Fix Common Study Tagging File XML Errors
Apr11

How to Fix Common Study Tagging File XML Errors

Study Tagging Files XML is a very common area of confusion for most people new to eCTD and XML in general. I have spent a lot of time creating the XML for sequences by hand, and have examined sponsors’ XML to determine the location of the error. Because of these experiences, I thought it would be beneficial to discuss the basic structure of the index.xml, stf.xml, and the single most common question I receive related to the STF which is, “Why am I seeing errors 1952, 1953 and are these the same error?”

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eCTD Publishing Best Practices
Mar09

eCTD Publishing Best Practices

People seeking advice on eCTD publishing best practices usually fall into one of two groups: (1) Sponsors who are new to eCTD, for example, medical writers or project managers (2) eCTD publishers. The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions.

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Free Educational Webinar: FDA Review Process

Update: the webinar slides are now available for download here. Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, March 1st at 3pm EST. The purpose of this webinar is to provide you with the complete FDA review process to make sure that you...

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EU Publishes Updated Validation Criteria

Today, EMEA posted an updated version of EU eCTD Validation Criteria (V2.1) on their eSubmissions: What’s New page. Changes are minor and include: Introduction of new check 11: “The checksum of the index.xml, when calculated by the validation tool, should match the checksum provided in the index-md5.txt” [This is pretty straightforward and was already being checked at the FDA.] Change in the category of check 10 “The regenerated...

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