In the chaos of the holidays, you might have missed the release of an important new guidance from FDA. On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at the recent DIA Electronic Submission conference to release the document by year’s end. This new version is a welcome update to a guidance that was last revised in June 2008.
Some highlights of the guidance include:
- FDA will now accept documents in PDF Version 1.7 (PDF Version 1.4 remains the minimum version required). As GlobalSubmit’s Rahul Mistry recently reported, the ICH specification will also soon be updated to allow PDF Version 1.7 as well.
- All fonts should be embedded in PDF documents to ensure that documents are readable by FDA reviewers. As an extra measure to ensure readability, the guidance also includes a list of standard fonts that FDA recommends you stick to when creating documents.
- Documents should be set up to print on 8.5 by 11 inch paper; however, there is an exception for oversize documents such as CAD drawings or promotional materials. These documents should be provided in their actual page size.
- The guidance provides information on image compression and optimization settings to minimize PDF file sizes.
The full guidance is only six pages long, so I encourage all eCTD submission publishers to download and read it today.
UPDATE (20 January 2012): FDA updated the guidance to clarify the language on acceptable PDF versions for documents. The link above points to the updated version of the guidance.
Related articles:
- FDA and PDF Specifications: An Evolving Matter (theectdsummit.com)
- Using Older PDF Versions (theectdsummit.com)
- Transitioning from Paper to eCTD (theectdsummit.com)
- Multiple eCTD Sequences in One Day? (ectdtips.com)
- Pre-IND Submissions in eCTD Format (ask-cato.com)
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