Many of you are already familiar with the FDA’s Electronic Regulatory Submissions and Review pages. Within the next few weeks, look for a significant update to these pages.
Some planned changes include:
- Considerable re-organization, including creating new pages and deleting existing pages (so you may have to update your favorites and shortcuts)
- Clarification concerning some recent changes. For example, you may have noticed that the link entitled “eCTD Backbone File Specification for Modules 2 through 5 3.2.2” now points to the ICH eCTD 3.2.2 spec, instead of the FDA’s document, but to date they had not commented on this or formally withdrawn their own document. They will clarify this when they update their pages.
- At some point shortly after the re-organization, they will post updated validation criteria. This development has been awaited for some time by sponsors, as the FDA moved to a new version of their validation software (GlobalSubmit VALIDATE 5) last November but had not yet posted the updated criteria associated with the new version.
Updates to electronic forms are not part of this effort. There is a separate working group with a goal of standardizing all of the forms and making them fillable.
I will highlight the update and any significant changes when it takes place. If you want to avoid having to check in, I suggest that you add this blog as an RSS feed (see the top left of this page or use your IE toolbar) and then you will receive a notification email.