PDF Document FAQs

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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 FDA updated their PDF Specification in December 2011 to allow PDF versions 1.4 through 1.7. The ICH recently discussed this specification, and agreed to accept version 1.7 and will soon issue new standards.

Q: Do I need to upgrade my PDFs to the current version 1.7?

A: No. The specifications for PDFs 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.

Q: Can I submit a PDF version older than v1.4?

A: Yes, for the same reason stated in the previous answer. PDF versions are backward inclusive.

Q: Which version of Adobe Acrobat is the FDA using?

A: The FDA recently upgraded from Adobe Acrobat 8 to the new version, Adobe Acrobat X.

Q: Can I have too many or too few hyperlinks?

A: Yes. I have heard from reviewers that submissions do not contain enough hyperlinks. I have also heard of submissions that contain too many links. Unfortunately, hard and fast rules concerning the number of links do not exist. Nevertheless, representatives from the FDA have conveyed some clear messages concerning hyperlinks in public forums through presentations such as this.

Hyperlinks are very important to the review process as they maximize the usefulness of receiving an eCTD submission. Hyperlinks that are not functioning properly erode the reviewer’s confidence in the submission and should be avoided. Some common errors include hyperlinks that go to the wrong document or the wrong page, or that simply do not work.

Still have questions? Stop by the GlobalSubmit booth at the DIA Annual Meeting in Philadelphia, PA on June 25-27th and we’ll be happy to answer your questions on PDFs, eCTD related topics, and more! We hope to see you there!


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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