Contains Nonbinding Recommendations
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submissions are loaded onto network servers; both absolute links that reference specific drives and
links to root directories do not work once the submission is loaded.
The document TOC helps the reviewer navigate to the information of interest within the document
that is not provided in the submission table of contents. For documents with a table of contents,
provide bookmarks and hypertext links for each item listed in the table of contents including all
tables, figures, publications, other references, and appendices that are essential for navigation
through documents. The use of invisible rectangles and blue text in the table of contents for
hypertext links avoids obscuring text. Other help for navigation includes a bookmark hierarchy
identical to the table of contents; up to four levels deep in the hierarchy.
When creating bookmarks and hyperlinks, set the magnification setting to “Inherit Zoom” so the
destination page displays at the same magnification level used in the primary document.
INITIAL VIEW SETTINGS
Set the Navigation Tab to open to “Bookmarks Panel and Page.” This sets the initial document
view when the file is opened. If there are no bookmarks, set the Navigation Tab to “Page Only.”
Page Layout and Magnification should be set to “Default.”
PAGE NUMBERING
In general, it is easier to navigate through an electronic document if the page numbers for the
document and the PDF file are the same, with the initial page of the document numbered as page
one. There is an exception when a document is split because of its size and the second or
subsequent file is numbered consecutively to that of the first or preceding file.
NAMING PDF FILES
Use lower case characters and avoid using special characters except hyphens and underscores in
file names. Special characters to avoid include punctuation, spaces, or other non-alphanumeric
symbols. The current FDA validation criteria and the ICH eCTD specification both provide
additional guidance on allowable special characters in file names.
SPECIAL CONSIDERATIONS FOR PROMOTIONAL LABELING AND ADVERTISING
MATERIAL
Promotional materials submitted in PDF format may need special consideration to ensure accurate
representation of the actual image. PDF restrictions for font size, color, and annotations stated in
this document are not applicable to these materials. Since color varies from monitor to monitor, it is
difficult to ensure that the reviewer will see exactly the same color as in the actual image. Provide
images at the highest resolution and depth practical. For photographs, the image should be
obtained with a resolution of at least 600 dpi. Documents that are available only in paper should be
scanned at resolutions that will ensure the pages are legible both on the computer monitor and when
printed; at least 600 dpi is recommended. Promotional material should be submitted according to