Posts in Category "PDF Versions and Format"

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.

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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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