New York, NY – 2 June 2009 -- PharmaPendium (http://www.info.pharmapendium.com), Elsevier's online resource for authoritative preclinical, clinical and post-marketing drug information, has significantly expanded its coverage of US Food and Drug Administration (FDA) approval documents with the launch of the FDA Classic Collection. This collection contains all available historical FDA approval documents up to and including those issued in 1991 – all indexed and made searchable for the first time in history. With the addition of the FDA Classic Collection, PharmaPendium has become the only integrated, searchable source of all FDA drug approval documents.
The combination of PharmaPendium's current FDA database and the FDA Classic Collection creates an entire searchable library of documents written by the FDA on the approval of drugs and their pharmacokinetics, efficacy and safety. The FDA Classic Collection may be searched simultaneously with the current file (1992-present) or as a discrete database.
"For success within the pharmaceutical industry it's critical to gain and maintain a strong competitive advantage and avoid lost opportunities, lost sales, wasted trials and regulatory recycling. The addition of the FDA Classic Collection to PharmaPendium gives pharmaceutical companies the advantage of being able to gain a unique perspective into the past, enabling them to benefit from information that has not been available for close to 50 years. Users will be able to apply modern analyses tools to these data for the first time, generating new insights. They will no longer encounter information dead ends because every citation to a previous FDA document is now traceable, searchable and viewable," commented Philip MacLaughlin, Senior Product Manager at Elsevier.
Most of the documents in PharmaPendium's FDA Classic Collection were previously available only through direct requests to the FDA/Center for Drug Evaluation and Research Freedom of Information Office and had to be pulled from microfiche. "Now users can locate and search these historic documents in just seconds to uncover regulatory precedents, learn from historic mistakes and successes and apply these lessons to current projects in the drug pipeline," continued MacLaughlin.
The FDA Classic Collection may be added to new or existing PharmaPendium licenses for an additional fee.
About PharmaPendium™
PharmaPendium, The Essential Resource for Preclinical Safety and Risk Assessment, is a unique online resource that provides access via a single point to searchable and trusted drug information. It covers over 3100 approved drugs, with integrated preclinical, clinical and post-marketing safety data.
PharmaPendium is designed to meet the needs of preclinical safety assessment teams, toxicologists, pharmacokineticists, safety pharmacologists, regulatory affairs staff, pharmacoepidemiologists, clinical researchers 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. CrossFire and Reaxys, EMBASE and PharmaPendium. More information can be found at www.elsevierforindustry.com.
About Elsevier
Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health communities, Elsevier's 7,000 employees in over 70 offices worldwide publish more than 2,000 journals and 1,900 new books per year, in addition to offering a suite of innovative electronic products, such as ScienceDirect (http://www.sciencedirect.com), MD Consult (http://www.mdconsult.com), Scopus (http://www.info.scopus.com), bibliographic databases and online reference works.
Elsevier (http://www.elsevier.com) is a global business headquartered in Amsterdam, The Netherlands and has offices worldwide. Elsevier is part of Reed Elsevier Group plc (http://www.reedelsevier.com), a world-leading publisher and information provider. Operating in the science and medical, legal, education and business-to-business sectors, Reed Elsevier provides high-quality and flexible information solutions to users, with increasing emphasis on the Internet as a means of delivery. Reed Elsevier's ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).
PharmaPendium is a trademark of Elsevier Inc.