Rolling eCTD Submissions a Good Fit for Expedited FDA Programs
Apr13

Rolling eCTD Submissions a Good Fit for Expedited FDA Programs

A rolling submission is done in waves. Sponsors submit completed sections for review, as opposed to waiting for the entire application to be finished. Smaller portions, as opposed to one large submission, are well suited for projects granted accelerated review timelines. We’re seeing that the means to pull off a rolling submission are available and the awarding of expedited pathway designations is motivating sponsors to proceed with a sense of urgency.

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FDA to Answer ESG Submission Surge with Usability Enhancements
Feb16

FDA to Answer ESG Submission Surge with Usability Enhancements

More than 3 million submissions were received via the ESG in 2015, and FDA representatives are estimating 7 million submissions for the year 2016. The volume increase is quite substantial considering 11.3 million submissions passed through the ESG in the previous 10 years (January 2006 to January 2016). Small user improvements planned by the FDA, and announced at DIA RSIDM 2016, will make life easier for sponsors who are growing more dependent on their Gateway accounts.

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Transitioning from Paper to eCTD
Sep07

Transitioning from Paper to eCTD

The most frequently asked question related to the conversion from paper to eCTD is, “Are we required to resubmit everything we’ve previously submitted in paper to the ‘new’ eCTD application?” Thankfully, FDA does not require you to resubmit information that was previously submitted in paper. However, you may find it useful to occasionally “backfill” your eCTD application by resubmitting previously submitted information for the convenience of the FDA reviewers.

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eCTD Publishing Best Practices
Mar09

eCTD Publishing Best Practices

People seeking advice on eCTD publishing best practices usually fall into one of two groups: (1) Sponsors who are new to eCTD, for example, medical writers or project managers (2) eCTD publishers. The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions.

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An Aggregation of Recent eCTD News, Part II

As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news: CMD(h) issued a new Best Practice Guide on the use of eCTD in the MRP/DCP. Dr Martin Moxham of iRegulatory provided an excellent review of the updated CMDh best practice guide. CMDh also posted Contact E-Mail Addresses For Submission Of Electronic Response Documents During Mutual Recognition & Decentralised...

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