In February 2004, the FDA issued a Draft Guidance requiring the electronic submission of labeling content to be provided in an XML-based format called Structured Product Labeling (SPL). The purpose of this white paper is for the reader to gain an understanding and prepare for the FDA's new electronic labeling submission standard.
P T C . c o m
White
Paper--An
Introduction
to
Structured
Product
Labeling--Page
1
of
12
An
Introduction
to
Structured
Product
LabelingUnderstanding
and
Preparing
for
the
FDA's
New
Electronic
Labeling
Submission
StandardP T C . c o m
White
Paper--An
Introduction
to
Structured
Product
Labeling--Page
2
of
12
Table
of
Contents
Overview
...............................................................................................................3Who
Should
Read
This
Document
...........................................................................3Executive
Summary...................................................................................................3What
is
SPL?
..........................................................................................................3Why
a
Standard
for
Labeling
Content?
.....................................................................4Flow
of
SPL
Content
...........................................................................................4Background
of
SPL...................................................................................................5Development
of
SPL
Specification
...........................................................................5Adoption
of
SPL
by
FDA.......................................................................................5SPL
Working
Group
............................................................................................5Ownership
of
SPL
Standard
...................................................................................5Who
is
HL7?.....................................................................................................6Structured
Labeling
Content........................................................................................6Structured
vs.
Non-structured
Documents
.................................................................6Benefits
of
XML
in
Life
Sciences
.............................................................................6Components
of
an
SPL
Document.................................................................................7SPL
Header
......................................................................................................7SPL
Narrative
....................................................................................................7SPL
Structured
Data............................................................................................8SPL
Compliance.......................................................................................................8Timeline
for
Submission
Requirements......................................................................9Steps
Required
to
Achieve
Compliance......................................................................9Approaches
for
Producing
SPL-Compliant
Submissions..................................................9Retain
Current
Processes
................................................................................9Integrate
Microsoft
Word-based
Tools
................................................................9Migrate
to
XML
Environment...........................................................................
10Enterprise
Benefits
of
Structured
Product
Information.........................................................
10SPL
Resources
.........................................................................................................
12Conclusion.............................................................................................................
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