Does the FDA Accept PDF/A?

Recently a client asked me if the FDA would accept a PDF/A document. The short answer is yes, but I would not build your system based on the PDF/A standard. I will explain why below. PDF/A is an ISO-standardized version of the Portable Document Format (PDF) specialized for the digital preservation of electronic documents. PDF/A differs from PDF by omitting features ill-suited to long-term archiving, such as font linking (as opposed to...

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Regulatory Publishing Considerations for Literature References

eCTD submissions frequently include literature references that are submitted to support aspects or statements made within the application. The articles that are provided in the submission are typically from scientific or medical journals that have been downloaded by the sponsor from sources such as the publisher or a service provider like Thomson Reuters. Downloaded articles are commonly formatted following a set of standards that do...

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PDF Document FAQs

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...

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FDA Accepting PDF 1.7 and Older Versions

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.

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FDA PDF Specifications

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.

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