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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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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eCTD Cross Application Links

A little while ago, a client asked me about referencing documents submitted in one application from another application. Her question was in the context of an IND and an NDA, both submitted in eCTD format – did she have to re-submit documents in her NDA that had already been submitted in her IND? The ICH guidance is basically silent on this subject, although the structure does not specifically prohibit any valid relative link....

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Advantages of Electronic Submissions vs. Paper

I attended a session at the DIA annual meeting where the regulators spoke about the status of eCTD in their regions. I’ll give some updates from EU and Japan in my next post; today’s post focuses on FDA updates. Gary Gensinger gave the US eSubmission update. The most interesting point that Gary made was in the “myth busting” department. Gary told us “There is no advantage to submitting in paper over...

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