Elsevier Adds FDA Advisory Committee Content to PharmaPendium(TM)
By Elsevier, PRNETuesday, March 30, 2010
Offers Preclinical, Clinical Drug Development and Regulatory Affairs More Access to Comparative Data
NEW YORK, March 31, 2010 - PharmaPendium (www.info.pharmapendium.com/), Elsevier
announces a new release that adds extensive FDA Advisory Committee content to
the online resource for authoritative preclinical, clinical and post-market
drug information. These documents provide preclinical and clinical drug
development and regulatory affairs departments with a substantial collection
of comparative scientific and regulatory data that may not be included in
final FDA Approval Package documents. For the first time FDA Advisory
Committee content and FDA Approval Packages can be searched simultaneously
via a single source on PharmaPendium.
"The addition of FDA Advisory Committee content, one of our
top priorities in response to user demand, gives preclinical safety and
regulatory affairs access in a searchable format to data that may not be
included in final FDA approval documents. It affords a valuable window into
the FDA approval process," commented Philip MacLaughlin, Senior Product
Manager at Elsevier. "It supports the analysis and leveraging of regulatory
precedent and experimental data so that companies can speed the approval
process, avoid regulatory cycling and learn from the experience of others."
This expansion of searchable FDA approval coverage gives
pharmaceutical and biotechnology companies deeper insights into regulatory
context, precedent content and the FDA drug approval process. Organized by
committee, more than 140,000 pages of FDA Advisory Committee meeting minutes,
rosters, supplementary documents, transcripts and PowerPoints are being
added. Content from 19 CDER and CBER committees is represented.
PharmaPendium is designed to support both scientific and
business decisions within the pharma/biotech industry.
About PharmaPendium(TM)
PharmaPendium (www.info.pharmapendium.com/), allows the
user to make informed drug development decisions. It, is a unique online
resource that provides access via a single point to searchable and trusted
drug information. It covers close to 4,000 approved drugs, with integrated
preclinical, clinical and post-market safety data.
PharmaPendium is designed to meet the needs of preclinical
safety assessment teams, toxicologists, pharmacokineticists, safety
pharmacologists, regulatory affairs staff, pharmacoepidemiologists, clinical
researchers, drug discovery informatics and information specialists. It
enables text-search of FDA Approval Packages and European Medicines Agency
(EMEA) European Public Assessment Reports (EPAR) Approval Documents as well
as other data sources. Adverse events and toxicity data are carefully
extracted from preclinical and clinical studies from all of these sources.
Elsevier offers a broad spectrum of solutions to make processes in drug
discovery, preclinical and clinical drug development more efficient, e.g.
Reaxys (www.info.reaxys.com), Embase (www.info.embase.com) and
PharmaPendium (www.info.pharmapendium.com). PharmaPendium is owned and
protected by Elsevier Properties SA and used under license.
About Elsevier Properties SA
Elsevier Properties SA is a center of excellence within Reed
Elsevier for the management of intellectual property. Elsevier Properties SA
owns the PharmaPendium, Beilstein and Reaxys databases. Trademarks including
Reaxys(R), PharmaPendium(TM) and The Lancet(R) are owned and protected by
Elsevier Properties SA and used under license. For additional information see
www.reedelsevier.com.
About Elsevier
Elsevier is a world-leading publisher of scientific, technical
and medical information products and services. The company works in
partnership with the global science and health communities to publish more
than 2,000 journals, including The Lancet (www.thelancet.com) and Cell
(www.cell.com), and close to 20,000 book titles, including major
reference works from Mosby and Saunders. Elsevier's online solutions include
ScienceDirect (www.sciencedirect.com), Scopus (www.scopus.com),
Reaxys (www.reaxys.com), MD Consult (www.mdconsult.com) and
Nursing Consult (www.nursingconsult.com), which enhance the
productivity of science and health professionals, and the SciVal suite
(www.scival.com) and MEDai's Pinpoint Review (www.medai.com),
which help research and health care institutions deliver better outcomes more
cost-effectively.
A global business headquartered in Amsterdam, Elsevier
(www.elsevier.com) employs 7,000 people worldwide. The company is part
of Reed Elsevier Group PLC (www.reedelsevier.com), a world-leading
publisher and information provider, which is jointly owned by Reed Elsevier
PLC and Reed Elsevier NV. The ticker symbols are REN (Euronext Amsterdam),
REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).
Tom Reller, VP, Global Corporate Relations, +1-215-239-3508,
T.Reller@elsevier.com
Tom Reller, VP, Global Corporate Relations, +1-215-239-3508, T.Reller at elsevier.com
Tags: Elsevier, March 31, New York, United States of America