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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FDA Statistics on NDAs, INDs and ANDAs

This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area. However, a lot of interesting information was exchanged. Today, I’ll focus on the FDA’s presentations. I’ll follow up later with information from other authorities and industry. Gary Gensinger provided his usual update on eSubmissions at the FDA: In the CDER town hall meeting, Gary noted that FDA...

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GlobalSubmit Exhibiting at DIA Annual Meeting in San Diego

The DIA Annual Meeting will be held in San Diego June 20-25.  If you are attending and we haven’t met yet, I’d love to meet you!  Look for me in our booth, 923 (get your badge scanned to enter a drawing for our extremely cool giveaway – I’m not going to reveal what it is).  I’ll be joined in the booth by my collegues and well-known industry experts Jason Rock and Rahul Mistry. I’ll also be in some...

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