22 November 2011

THE eCTD SUMMIT: FDA and PDF Specifications: An Evolving Matter - By Rahul Mistry

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.

To find more information please click here: THE eCTD SUMMIT: FDA and PDF Specifications: An Evolving Matter - By Rahul Mistry

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