As many of you know, the FDA issues eCTD Guidance and Specifications to clarify implementation of regulations. In the currently posted specification concerning PDFs dated June 4, 2008, the official PDF version is 1.4, which is supported in Adobe Acrobat 5 and later. As new versions of the PDF specifications are released, they are evaluated for future acceptance. Therefore, the answer to the question “Which version of PDF can I submit?” changes as the PDF standards evolve.
The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.
The role of eCTD-ready source documents and their impact on submission timelines and publishing efficiency is a topic that has been debated for many years. There a lot of naysayers claiming that it’s not possible to compel scientists to produce submission-ready documents, CROs cannot be made to comply with requirements, etc.
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.
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...