Posts in Category "PDF Creation"

Can new versions of Acrobat create a PDF 1.4 File for FDA Submissions?

Every so often I will hear from a bio-pharma customer who will tell me something similar to this:

We can’t move to a newer version of Acrobat because we have to make PDF 1.4 files for agency submissions.

Put succinctly— that just isn’t true.

The PDF Version is not the same as the version of Acrobat.

Acrobat XI (and previous versions) can easily save back to previous versions.

In fact, you can set Acrobat to create files in the version you want all the time, by adjusting a few simple settings.

I’ve previously written about two related topics:

In this article, I will discuss how to:

  1. Saving and Loading PDF Settings
    1. Save out an older PDF setting to move to a new system
    2. Load a PDF setting into Acrobat
  2. Setting the default PDF Setting for:
    1. PDF Print Driver
    2. Word, Excel and PowerPoint
    3. Creating PDF from the desktop, in batch or when combining documents
  3. Tips for Setting Defaults when deploying Acrobat

Read on to learn more.

Continue reading…

Batch Conversion of Excel Files to PDF

I recently received the following inquiries from customers::

Some of my Excel files contain more than  one worksheet. I would like to convert the second worksheet in an Excel file to the same PDF.

I have over 1000 Excel documents to convert to PDF as part of a regulatory filing. Is there a way to convert these all to PDF in batch?

I’ll tackle both of these needs in this article.

Converting Multiple Worksheets

Fortunately, Acrobat 8 and later can easily convert all of the worksheets in your Excel files to PDF:

Excel file with multiple worksheets

When you use the PDF Maker in Acrobat 9, you have some additional options to select just the worksheets needed:

Excel conversion window in Acrobat

A) Choose options to convert all worksheets, the currently selected worksheet or a subset of the worksheets.

B) To choose some worksheets, but not others, select from the list on the left and use the Add or Remove buttons to move them to the list on the right.

C) Click the Convert to PDF button to complete the process

The result is a nicely bookmarked PDF that looks like this:

A nicely bookmarked PDF created from Excel

What about batch conversion?

If you want to convert many Excel documents in batch to PDF, there are a few additional tricks involved. Read on learn how in the rest of the article.

Continue reading…

Batch Conversion of Text Files to PDF

,,

Not long ago, I heard from a large pharmaceutical company working on a new drug submission. As part of the process of testing the new compound, they had written over one thousand Visual Basic programs to process and organize data.

Text File Pic

In communication with FDA staff, they learned that they would be required to submit the computer code for these programs for review by the agency.

As you might guess, the prospect of opening the code for each program individually in a word processor and converting to PDF was not appealing.

Was there a way to automate the process that would also allow control over fonts, layout and the version of PDF needed for submission?

Yes, this is possible using Acrobat 8 Professional.

Read on to learn about Batch Conversion of Text Files to PDF.

Continue reading…

FDA 1572 Forms: Convert or not?

,

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.

Continue reading…

Acrobat Font Embedding for FDA Submissions

,,,

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 . . .

Continue reading…