El personal científico del Centro de Evaluación e Investigación de Fármacos (Center for Drug Evaluation and Research, CDER) del FDA, está utilizando la herramienta RetrievalWare del fabricante de software de búsqueda y categorización para empresas y organismos gubernamentales para mejorar la productividad de las labores de regulación de fármacos, previa a la aprobación de los mismos y para el seguimiento post-marketing del departamento USA.
VIENNA, Va.–June 22, 2004– Convera, a leading provider of search and categorization software for enterprises and government agencies, today announced expanded use of the company’s RetrievalWare search technology by approximately 2,500 scientific review staff within the Center for Drug Evaluation and Research (CDER) at the FDA. The FDA’s CDER uses RetrievalWare for enhancing scientific productivity during drug regulatory responsibilities, prior to drug approval and for post-marketing surveillance of drugs.
Recently RetrievalWare’s use was expanded to provide easier access to an even larger breadth of research related libraries, including data from the Office of Generic Drugs and the Division of Counter-Terrorism.
Within CDER, RetrievalWare’s enterprise search capabilities are instrumental in helping drug reviewers identify precise drug related details within FDA generated correspondence and within massive libraries of documents related to pharmaceutical submissions.
Under time constraints for reviewing data, CDER’s scientific staff use RetrievalWare to extract specific information quickly during the extensive evaluation and approval process. In addition to other search functionality, RetrievalWare provides full content searches within PDF, XML, text and HTML documents, enabling reviewers to efficiently:
? Find prior drug product information, including previous FDA drug reviews and correspondence or documents
? Identify other similar drug products, which may already be available or awaiting approval
? Research across a set of drug product data for the probability of drug interactions
? Determine if pharmaceutical companies are complying with government regulations involving marketing, labeling and safety.
An essential component of the drug review process, the Adverse Events Reporting System reports on patients that have experienced adverse medical reactions to drugs. Integrated with the electronic data from this system, RetrievalWare also searches the system’s 3 million reports, allowing reviewers to quickly and easily pinpoint adverse human reactions. RetrievalWare also helps reviewers find associated drug details required during drug submission reviews, as well as identify problems with drug products already being marketed.
«Chemists, statisticians, drug safety evaluators, quality assurance specialists, medical officers, microbiologists, pharmacists and pharmacologists are some of the CDER staff that depend on RetrievalWare to identify precise research data from their search queries within CDER’s enormous libraries,» said Helen Mitchell, Product Manager, Enterprise Search, CDER/FDA. «The ability provided by Convera’s technology to perform full content searches and/or metadata searches has helped improve the quality and timeliness of the drug review process by helping facilitate quicker access to details our reviewers rely on for drug evaluations.»
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