Hyperlinking in eCTD Submissions FAQs
Dec07

Hyperlinking in eCTD Submissions FAQs

During several presentations, representatives from the FDA have conveyed some clear messages concerning hyperlinks. The general takeaway is that hyperlinks are very important to the review process as they maximize the usefulness of receiving an eCTD submission.

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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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