Last month, I attended a conference focused on pharmaceutical regulatory writing and submissions in Baltimore, MD. During the two-day conference, a number of discussions and questions pertained to PDF files. As many of you may have similar questions or experiences, I wanted to share the questions and answers to provide some greater insight into PDFs in relation to electronic submissions. Q: What versions of PDFs are acceptable? A: The...
the FDA currently accepts PDF 1.4 and will soon except PDF 1.7. Does this mean that you need to upgrade all of your PDF’s from 1.4 to 1.7? The very simple answer is no. The specifications for PDF are backward inclusive. This means that the PDF 1.7 specification includes all of the functionality previously documented in the Adobe PDF Specifications for versions 1.0 through 1.6.
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.
Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.
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.