STM publisher Elsevier, Netherlands, has announced that its online resource for authoritative drug safety data, PharmaPendium, 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. With the addition of the FDA Classic Collection, PharmaPendium claims to have 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.
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. The FDA Classic Collection may be added to new or existing PharmaPendium licenses for an additional fee.
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.
