Archive for November, 2007

FDA 1572 Forms: Convert or not?

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The U.S. Food and Drug Administration (FDA) provides Statement of Investigator forms—commonly known as 1572 forms— in downloadable PDF format.

The FDA's 1572 form
Download the form from the FDA (Opens in a new window)

The FDA-supplied 1572 form is an XML-based form in the Acrobat 7 file format (PDF version 1.6). The date on the form indicates that it is valid through May 31, 2009.

XML-based files are convenient for data collection workflows and may be digitally signed using SAFE signatures.

However, for IND and NDA submissions, the FDA seems to insist on receiving Acrobat 5 (PDF 1.4) level files.

On the surface, it does seem that this is an example of the agency not following its own guidelines.

What should you do?

  • Submit the forms in the same format supplied by the FDA?
  • Convert the files to PDF 1.4?

In this article, I’ll discuss what I’m hearing from the various Pharma firms I work with and also suggest ways to convert these forms to Acrobat 5-level files.

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Change PDF Versions for FDA Compliance

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The Food and Drug Administration dictates the specific version of PDF that is accepted by the agency— PDF 1.4, the Acrobat 5 specification

Most operations in Acrobat produce a compliant PDF 1.4 file. For example, the PDF Makers in Word and Excel default to producing an Acrobat 5 level file.

In this article I’ll cover:

  • How to check the version of a PDF document
  • How to change the PDF version

I’ll also cover some other related topics about changing PDF version. Read on to learn more.

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Acrobat Font Embedding for FDA Submissions

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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 . . .

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