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FDA PDF Specifications v4 0 FINAL 9-26-2014

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FDA PDF Specifications v4 0 FINAL 9-26-2014
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    PORTABLE DOCUMENT FORMAT (PDF)   SPECIFICATIONS   Technical Specifications Document    This Document is incorporated by reference into the following Guidance Document(s):   Guidance for Industry  Providing Regulatory Submissions in    Electronic Format — Certain Human    Pharmaceutical Product Applications   and Related Submissions Using the   eCTD Specifications   For questions regarding this technical specifications document, contact CDER at esub@fda.hhs.gov or CBER at esubprep@fda.hhs.gov U.S. Department of Health and Human Services   Food and Drug Administration   Center for Drug Evaluation and Research (CDER)   Center for Biologics Evaluation and Research (CBER)   September 2014    PORTABLE DOCUMENT FORMAT (PDF)   SPECIFICATIONS   ii      Revision History Date Version Summary of Revisions 2005-04-08 1.0 Initial version 2008-06-04 2.0 Changed “  Bookmarks and Page ” to “  Bookmarks  Panel and Page ” in Open Dialog Box section 2011-12-20 3.0 Updated to align with ICH recommendation on PDF version 1.7; add “Purpose” section; clarify specifications related to security, usability, and  promotional materials; revise list of standard fonts; add PDF optimization; and incorporate editorial changes 2012-1-13 3.1 Clarified language on acceptable PDF versions for documents; added page numbers 2014-9-26 4.0 Updated to align with ICH recommendation on PDF/A; clarify embedding of fonts and font size in embedded images; revise specifications related to document naviagation; and indicate maximum allowable PDF file size iii      Table of Contents PURPOSE ........................................................................................................................................... 2   VERSION ........................................................................................................................................... 2   SECURITY ......................................................................................................................................... 2   FONTS ................................................................................................................................................ 2   PAGE ORIENTATION ...................................................................................................................... 3   PAGE SIZE AND MARGINS............................................................................................................ 4   SOURCE OF ELECTRONIC DOCUMENTS ................................................................................... 4   METHODS FOR CREATING PDF DOCUMENTS AND IMAGES ............................................... 4   IMAGE COMPRESSION TO REDUCE FILE SIZE ........................................................................ 5   OPTIMIZE FOR FAST WEB VIEW ................................................................................................. 5   IMAGE COLOR MATCHING .......................................................................................................... 5   USE OF THUMBNAILS.................................................................................................................... 5   DOCUMENT NAVIGATION............................................................................................................ 5   INITIAL VIEW SETTINGS............................................................................................................... 6   PAGE NUMBERING ......................................................................................................................... 6    NAMING PDF FILES ........................................................................................................................ 6   SPECIAL CONSIDERATIONS FOR PROMOTIONAL MATERIAL ............................................ 6   i  

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