The U.S. Food and Drug Administration sets guidelines for electronic regulatory submissions for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
The agency has long relied upon PDF because of Acrobat’s ability to faithfully render all aspects of printed pages including layout, tables, images and fonts (typefaces).
The last item—fonts—is a critical aspect of displaying documents.
Acrobat offers three choices that balance file size versus absolute fidelity:
- Font Substitution
Acrobat renders—on the fly—a “faux font” representation using typeface information included in the PDF.
- Font Subsetting
Only the typeface characters necessary to render the file are embedded. Typefaces may have thousands of characters. Only embedding the actual characters used can reduce file size.
- Font Embedding
All typefaces necessary to render a font are embedded in the file.
While Font Substitution keeps file sizes small, it can be problematic for submissions as non-standard fonts and specialized math symbols may not render faithfully for reviewers.
Font Subsetting is a tempting choice because it renders all the characters in a document accurately while keeping file size to a minimum. However, subsetting can result in “file bloat” if you regularly combine files. The Acrobat Distiller Reference Manual discusses this issue:
When Acrobat merges two PDF files, each containing a subsetted version of the same font, it produces a new PDF file that retains both subsetted fonts. The net size of the two subsetted fonts may be larger than the full font would have been.
For the reasons cited above, the FDA recommends that all fonts used in PDF submissions be completely embedded. See Providing Regulatory Submissions in Electronic Format – General Considerations.
Unfortunately, the “Standard” conversion setting in Acrobat does not embed the most common office fonts. These fonts such as Arial and Times Roman are normally installed as part of the operating system.
A recommended best practice is to create a new PDF Conversion setting which embeds all fonts and use it for creating all PDFs.
Read on to learn how . . .
Creating an “Embed All” Setting
Follow these steps to create PDF setting that embeds all fonts:
- In Acrobat, choose Edit—> Preferences.
- Click on the Convert To PDF category item in the list at left
- Select Microsoft Word from the middle list
- Click the Edit Settings button
- In the Adobe PDF Settings window, click the Edit button:
- Select the Fonts category from the list at left and uncheck “Subset Embedded Fonts… “
- Select all the fonts listed in the "Never Embed" list on the right. Click the Remove button.
Tip: Shift-click to select multiple entries in the list.
- Click the Save As . . . button:
- Name the file. It will be saved in the users default Acrobat job options folder:
- Click Save, then OK twice.
Multiple Ways to Create PDF
Acrobat offers a multitude of methods for creating PDFs from Office documents:
- Via the AdobePDF Print driver
- Via the PDFmaker buttons installed into popular office applications
- By combining native documents using the Combine function in Acrobat
Each approach will require some set-up to ensure that all documents created have fonts embedded.
Setting Embed All for the Adobe PDF Print Driver
Follow these steps to set the Adobe PDF Print Driver to always use the Embed All setting:
- From any application, choose File—> Print.
- Select the Adobe PDF from the Name list.
Click the Properties button
- Choose the Embed All from the Default Settings list
Setting the Embed All setting for Office PDF Makers
Acrobat Professional installs 1-button PDF conversion toolbars and menus into popular Office applications such as Word, Excel, PowerPoint, Visio, Project and Internet Explorer.
Follow these steps to set an Office PDFmaker button to always use the Embed All setting. The example below is from Microsoft Word.
- Launch the application of your choice, but do not open a document.
- Choose AdobePDF—> Change Conversion Settings
- Choose Embed All from the Conversion Settings list
- Click OK
Setting Embed All for Combine or Create from Desktop in Acrobat
Acrobat allows users to convert several different kinds of native files using the Combine function or via the desktop.
When conversion takes place using these direct methods, you need to specify the desired conversion setting in Acrobat Preferences for each application supported.
- In Acrobat Professional, choose Edit—> Preferences
- Click on the Convert to PDF category from the list at left
- Click the Edit Settings button
- In the Edit Settings window, change the Conversion Setting to “Embed All”
- Click OK
- Repeat for all applications
Since it is not possible in Acrobat to embed missing fonts in a document after PDF creation, it is critical to choose the proper conversion setting in Acrobat.
Proper preparation of documents can avoid problems downstream.