FDA eCTD Review Process Q&A

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Earlier this week, GlobalSubmit and Cato Research held an educational webinar on the FDA eCTD Review Process. The purpose of the webinar was to provide an overview of the various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the United States.

During the webinar, GlobalSubmit’s CTO Jason Rock discussed the FDA’s workflow, the challenges they face in the electronic submission process and common errors in a submission. In addition, he shared some leading eCTD practices, while underlining the importance of using validation software when submitting eCTDs to ensure submission success.

We had a great turnout, and received several excellent questions from the audience. Though we were unable to address every question due to time restraints, Jason has reviewed all the questions submitted and provided answers below:

Q: How do you suggest we clean up metadata issues?   For instance, in your example of including the manufacturer with two different spellings…do you go back and delete leaves?

A:  If it is a minor issue such as a misspelled city or site name, then it is probably best just to remain consistent in the spelling in all subsequent submissions.  If it is a significant error, then you should delete/withdraw the entire section and resubmit.

Q: How does this presentation apply to ANDA eCTD submissions?

A:  The presentation generally applies to ANDA’s as well with the exception of the approval timeline which is different than for NDA’s.

Q: One of your slides referenced that the Viewer can’t open SAS files. What does the FDA want you to submit instead of SAS files for an ANDA?

A:  While it is true that GlobalSubmit REVIEW™ does not open SAS files in the preview pane, the reviewers at the FDA simply have to double-click on the .xpt document in GlobalSubmit REVIEW and the SAS file will open in SAS Viewer which all of the reviewers at the FDA have installed.

Q: Can you comment on submitting leaves at a lower level of granularity than those detailed in the FDA specs? For instance, submitting the Annual Report at 1.13 even though the specs state 1.13.1 – 1.13.x.

A: This question is not clear; however, node extensions (adding your own lower level of granularity) are strongly discouraged unless you have permission from the FDA.  The specifications around granularity are there to make the review process more efficient, so please use them when provided. That said, it is not uncommon for sponsors to use their own judgment and submit items at a higher level.

Q: At what point do you get the ACK message from the Gateway?

A: The acknowledgment response should come instantly, but typically you will receive it within 48 hours.

Q: Were you planning to demonstrate how the FDA views the submissions in GlobalSubmit?

A:  Yes, GlobalSubmit has monthly open web demonstrations that you can find listed on the events page of website.  Alternatively, you can contact our Marketing team to be added to our mailing list, so that you are notified of these monthly events.  Or you can contact our Sales team directly to schedule a personal web demonstration.

Q: Is there any coordination between FDA and EMA new validation requirements? And how will that affect vendors and their tool upgrades?

A:  The coordination that occurs between the FDA and EMA happens at ICH and is around standards; details are not coordinated.  GlobalSubmit software captures and maintains all of the errors of the FDA and EMA as well as Health Canada and Swissmedic.  We cannot speak to how other vendors support the validation criteria and their upgrade processes.

Q: Can you please let me know about Study Tagging Files and Node Extensions in eCTD?

A:  This question is a little vague.  We will be happy to answer this question in more detail, please contact Candice.yarde@globalsubmit.com .

Q: How do we submit updated SDTM CRT files (e.g. ae.xpt with updated coding for summary or ISS) and original ones (which may have been used for the original CSR) in one submission?

A:  The guidance states to put all SDTM CRT files in a data set folder in M5 organized by study.  Each study needs to have an associated STF that links to each SDTM CRT file.  ISS and ISE should also use study tagging files.

Q: When is the US M1 item 1.15-Promotional Materials used? Is it for DDMAC submissions?

A:  DDMAC is not currently in eCTD yet, and the timeline is still undefined.

Q: Is there any tool which would make the scanned PDF documents ready which would reduce a lot of time in getting the documents ready as required for eCTD xml backbone?

A:  There are many tools which will convert a scanned document using optical character recognition (OCR), including Adobe.  Please note:  not all scanned documents have to be converted.

Thank you again to all of those who participated in the webinar. For your reference, the webinar slides are now available for download here. We look forward to seeing you at future events!we

Author: GS

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