FDA has officially released the Updated PDF Specification document (version3.0) on 20th December 2011.
In this document FDA has mentioned the applicant can use PDF Version 1.7 for documents however the applicant still submit their documents in version 1.4 – 1.7. Submitted PDF files should be readable by Adobe Acrobat 8.0.
The following key points FDA has updated in the updated PDF Specification version 3.0 document.
Special Consideration for Promotional Materials - Promotional materials submitted in PDF format may need special consideration to ensure that the accurate representation of the actual image. For photographs, the image should be obtained with a resolution of at least 600 dpi. Promotional material should be submitted according to its actual size when practical. When an image size is altered, the original dimensions must be stated. Images of three-dimensional promotional pieces must show all sides
and components.
Optimize the PDF for fast web view - While creating files from source documents use the “Optimize the PDF for fast web view” option to reduce file sizes and file opening times.
The “purpose of the document” section has been added in the document, FDA has revised some of the standard Fonts and gave more clarification about the security and usability PDF documents.
To find the document please click here
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