New York, NY – March 31, 2010 -- PharmaPendium, 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™
PharmaPendium, 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®, PharmaPendium™ and The Lancet® 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. The ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).