Impact of the FDA’s eCTD Mandate

With the FDA Safety & Innovation Act now signed into law, life science companies will need to start thinking strategically about the impact of the FDA’s eCTD mandate and how to quickly and easily comply. Since most of the larger companies already submit electronically, the greatest impact will be to the smaller, virtual companies that do not have substantial IT infrastructure in place, and lack the overall budgetary...

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Regulatory Publishing Software Q&A

During a recent webinar presentation, GlobalSubmit demonstrated how IND & Pre-IND companies use our software tools to see the same views as the FDA; build their application as the FDA sees it; cut days off the time it takes to quality check bookmarks and hyperlinks; improve communications both internally and with the Agency; improve efficiency and meet important deadlines; reduce risk of technical rejections; and more! We received...

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Advice for Sponsors New to eCTD

I often work with the Regulatory Operations department at Cato Research and I’m always impressed by the depth and breadth of their knowledge. Cato creates submissions for such a wide cross-section of the sponsor community that their associates have truly “seen it all”, and they can cite a precedent and define a best practice in response to almost any question they are asked. Recently, I took advantage of an opportunity to interview...

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Benefits of Submitting INDs in eCTD Format

On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference attendees included a number of smart and experienced eCTD professionals. During a round-table session, I asked the group if they were submitting INDs in eCTD format, and if so, why they felt there was value in doing so. I asked this question because at this date only 12% of INDs are submitted in eCTD format, and I’m curious as to why the number isn’t...

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Submitting Original INDs and Amendments in eCTD Format
Jan25

Submitting Original INDs and Amendments in eCTD Format

Acceptance of electronic submissions by small to mid-size early-stage pharmaceutical companies has been characterized by a slow, but steady, conversion to the eCTD standard, and nowhere is that fact more evident than in the rate of IND conversions to eCTD format. According to the FDA, 52% of original marketing applications and 83% of efficacy supplements are received in eCTD format, but only 12% of original IND submissions are in eCTD...

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