The eCTD Summit Celebrates 8th Anniversary with New Layout
Jan28

The eCTD Summit Celebrates 8th Anniversary with New Layout

While the online world has radically changed during the past 8 years, our approach of creating quality content has not. The eCTD Summit blog will continue to be a source of objective information on all things eCTD and regulatory submissions. Articles on the site are based on facts and stripped of bias. We want the site to be a trusted place our readers can regularly return to for updates on industry news, initiatives and best practices.

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Five Points to Consider When Selecting an Enterprise eCTD Viewer
Oct16

Five Points to Consider When Selecting an Enterprise eCTD Viewer

When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.

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FDA Module 1 Grouped Submissions Q&A
Jun26

FDA Module 1 Grouped Submissions Q&A

The current FDA specifications governing grouped submissions state that Application Type and Submission Type have to agree. Accordingly, you would have no trouble grouping NDA labeling supplements.

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Module 1 Grouped Submissions Explained
Jun19

Module 1 Grouped Submissions Explained

A grouped submission eliminates the need to submit multiple, identical submissions to different applications. For example, a manufacturing part change might impact a dozen applications. In the age of grouped submissions, a new sequence would be created to note the part change, and that sequence would then point to all other applications affected.

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FDA M1 Upgrade for Ad Promo Submissions
Jun12

FDA M1 Upgrade for Ad Promo Submissions

The M1 initiative, specifically the updated guidelines for Ad Promo submissions, is an example of the FDA gently nudging sponsors to adopt practices that will benefit industry as a whole. The draft guidance on the Ad Promo topic states “the Agency is currently able to process, review, and archive electronic formats in eCTD and firms are strongly encouraged to make such submissions electronically.”

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