Scanning, a Thing of the Past
Apr18

Scanning, a Thing of the Past

Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.

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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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Australia Set for eCTD Submissions Pilot Program
Jul01

Australia Set for eCTD Submissions Pilot Program

The Australian Therapeutic Goods Administration (TGA) appears ready to proceed with a pilot program that will pave the way for full adoption of eCTD submissions.

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FDA Online Instruction for eCTD Submissions

The CDER Small Business Assistance Program recently posted a web-based training course on electronic submission in eCTD format. The primary goal and purpose of CDER’s training is to encourage sponsors to submit in eCTD format. The training explains the FDA’s policies and practices regarding electronic submissions and provides sponsors with the fundamental information needed to submit new and transition old applications to...

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