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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@ or CBER at esubprep@
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 2016
v4.1
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 incorporat
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