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 PDF’s 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.
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