Stay Current on Guidance When Planning Your Submissions
(Note: This post is part of a multi-part series on the CTD this fall)
In my last post in the series we reviewed what we could find on the history of a main eCTD guidance. There are a fair number of eCTD related guidance, and they change frequently. For example, a draft guidance on submitting manufacturing establishment information issued in December 2016 was withdrawn in July 2019. Even the main eCTD guidance is on its third revision in as many years. Readers working on submissions should plan to spend significant effort staying current with eCTD requirements at the FDA’s eCTD program page. In my next post in the series, we’ll give an overview of the structure of the CTD, which provides the basis for the eCTD.
Reach out to me if you want to know more or discuss your medical product development challenges.
https://calendly.com/katrinarogers
Text Copyright © 2019 Katrina Rogers
Follow the links below to read each part of the series.
Electronic Regulatory Submissions Part 1
Electronic Regulatory Submissions Part 2
Electronic Regulatory Submissions Part 3
Electronic Regulatory Submissions Part 5
Electronic Regulatory Submissions Part 6
Electronic Regulatory Submissions Part 7
Electronic Regulatory Submissions Part 8
Electronic Regulatory Submissions Part 9
Electronic Regulatory Submissions Part 10
Electronic Regulatory Submissions Part 11
Electronic Regulatory Submissions Part 12
Electronic Regulatory Submissions Part 13
Electronic Regulatory Submissions Part 14