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LabelSentinel™ and LabelCompare™
Are you
Keeping Current with the Continual
Changes in Published
Labeling?
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Sponsors
need to be aware of, investigate and reconcile new SPL
versions published by the FDA on the NLM DailyMed
website. |
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Generic
manufacturers need to react to RLD publications. |
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Regulatory
Affairs needs to stay current with the changing labels
(yours and others') on NLM DailyMed and Drugs@FDA. |
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Labeling
owners need to quickly identify differences and
synchronize content with internal masters and active
copies. |
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Due
to FDA changes to submitted SPLs, sponsors—both
Innovators and Generic manufacturers—need to
monitor the NLM DailyMed SPL postings to: 1)
verify both “visible” narrative content and
“invisible” metadata content and 2) harmonize
all content for future submissions.
Reed
Technology understands the challenges in staying
current with new label postings by the FDA. The
additional tasks of continually watching for new
published labels and quickly reacting to the new
content places an unwanted burden on your
Regulatory Affairs' resources. Reed Tech can
help by providing fast, accurate and
comprehensive services that will ease your pain
in “staying current” and synchronizing your
internal “label master” for ongoing submissions
and downstream use (e.g. Printed Package Insert,
Final Package Labeling and other manufacturing
processes).
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LabelSentinel™ watches in
real-time for newly published labels on
the NLM DailyMed and the Drugs@FDA
websites. When we find a label on
your |
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custom “watch list,” we
send you an email alert. Your watch list
is based on filters such as title,
company, drug name, ingredient, NDC,
etc. |
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LabelCompare™ provides a
detailed comparison of two or more
labeling documents. They can be your
choice of
any versions:
internal, downloaded from |
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DailyMed (SPL
or SPL-PLR), downloaded from Drugs@FDA,
etc. A side-by-side Difference Report
and a detailed Comparison Analysis are
generated to focus your attention on
important differences. |
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Benefits
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Be
immediately aware of newly published labels |
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Quickly and accurately respond to
the NLM DailyMed SPL posting and synchronize content |
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Save time and concern by assuring
that your internal label master includes the latest
published content |
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Eliminate confusion among label
version differences |
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Key Features
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Custom
“watch list” of labels on NLM DailyMed and Drugs@FDA |
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Email alert of newly published
versions |
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Detailed analysis of changed
content, identifying significant changes that need
action |
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Highlighted changed content to
enable the synchronization of your “internal master” |
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“Exhibit data” for reconciling
issues with the FDA |
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LabelSentinel provides critical
notification of label postings. |
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Posting Date—when your labels are
publicly published (or updated) on NLM DailyMed and
Drugs@FDA |
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RLD
Postings—Generic manufacturers trigger their submission
plan based on the Reference Listed Drug publication |
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Market
Intelligence—know when other Innovators' or Generics'
drug labels (class or individual) have been published |
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LabelCompare
identifies and analyzes differences between
submitted and published content (any omissions,
additions or changes).
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Examines SPL documents, including:
Narrative—text, tables, lists, footnotes, reference
links, and images
Data Elements—heading, DLDE,
etc.
XML—tags, structure, syntax, etc. |
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Provides
“exhibit data” to resolve FDA published differences |
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Provides a
Difference Report and Comparison Analysis that focus
your attention on the significant differences |
Once you accept or
resolve the differences, Reed Tech converts the
newly established “internal master” into the
format of your choice (Word, PDF, Quark, etc.)
for ongoing submissions, active parallel
submissions under FDA review, and downstream
uses/processes such as manufacturing and
marketing. In addition to the narrative content,
metadata (Drug Listing and Highlights Data
Elements) can be extracted and recorded in a
Label Metadata Form.
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Contact Reed Tech for more information
Please
contact Ben McGinty, for more information about the
LabelSentinel and LabelCompare services.
Ben McGinty
Senior Director, Business Development
bmcginty@ReedTech.com
215-441-6466
Reed Technology and Information Services
Inc.
7 Walnut Grove Drive
Horsham, PA
19044
U.S.A.
215-441-6400
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Reed Technology and Information Services Inc. (Reed
Tech), based in Horsham, PA, is a leader in data capture, conversion and management. Reed
Tech is a member of the
LexisNexis Group headquartered in New York, NY, a leading global provider of comprehensive and authoritative legal, news and business information and tailored applications.
©
Reed Technology and Information Services Inc. All Rights Reserved. |
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