FDA PDF Specifications

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I am often asked, “Which version of Adobe Acrobat is the FDA using?”. This question is usually followed by, “Which version of PDF can I submit to the FDA?”.

The answer to the first question is that the FDA currently uses Adobe Acrobat 8 with plans of upgrading to the new version, Adobe Acrobat X, in the near future.

The answer to the second question is a bit more complicated. Since the FDA uses Adobe Acrobat 8, they have the ability to view PDF versions 1.0 to 1.7. That being said, they do not support all of these versions.

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. At the DIA Electronic Submissions Conference in San Diego held November 15th-17th, the FDA announced that it will now accept any PDF version between 1.4 and 1.7. While these are the acceptable versions stated by the FDA, earlier versions of PDF’s can still be submitted. See next week’s post.

I also learned that ICH members will also accept PDF versions 1.4 through 1.7 soon. Corresponding with this announcement, the FDA will update their PDF Specifications for the first time in over three years. The updated specification is scheduled to be posed by year end.


Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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