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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Extracting Information from PDF Forms Ranks as No. 1 FDA Processing Issue

At a  GPhA/FDA Labeling Workshop on April 14, 2010, Virginia Ventura of CDER’s Office of Business Informatics presented CDER Update eCTD & Gateway Submissions.  Along with lots of other useful information, Ms. Ventura provided an assessment of the current Top Processing Issues with Esubs: Description Percent of total Unable to extract info from PDF form (sponsor did not use fillable form) 52% Missing form (356h, 1571 or...

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ICH Working Group Making Progress on Next Major Version of eCTD

Last week I was at the ICH meeting in Japan. If you haven’t been to Japan, I highly recommend a visit to this beautiful country and its very friendly people. We had a productive meeting. My time was split between working on eCTD and ICSR. The eCTD group focused on change requests and requirements for the next major version. While there were no significant changes made, we are working hard to include Module 3 Q&A as soon as...

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Are Some Regional Health Authorities Only Accepting PDF Version 1.4?

Recently, some sponsors have been reporting the rejection of eCTD sequences or NeeS containing PDFs of any version other than 1.4. The Swedish agency Medical Products Agency (MPA) states on their website on the page Electronic submissions to the MPA “The MPA will check eCTDs against the A criteria listed in the “EU eCTD Validation Criteria” v.2.0 (see link to the right), and also check for the B criteria that the eCTD has PDF files in...

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