07.10.2014

FDA releases PDF specification 4.0

Flag of USA

The U.S. Food and Drug Administration (FDA) has released a new version 4.0 of their "Portable Document Specifications (PDF)". The PDF specification itself is referenced by the FDA "Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" that has been updated a few weeks ago.

Notable updates in the new version 4.0 are:

  • Alignment with ICH recommendation on PDF/A; PDF/A-1 and PDF/A-2 are explicitly acceptable now.
  • PDFs containing JavaScript and PDF annotations are not acceptable
  • Additional clarification has been included regarding the embedding of fonts (non-standard fonts should be fully embedded)
  • Fonts size from text that is included in embedded images should not be reduced below the recommended size (10-9pt in minimum);
  • Maximum allowable PDF size increased to 400 MB (previously 100 MB) per file
  • Additional guidance included regarding document navigation, in particular the presence of hypertext linked Table of Contents

For full details please see the original FDA PDF specification 4.0 available for download from the FDA website. In case of interest a "track change" version is available from infoatexalon.com. 

[Source: FDA]

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