Analyze the NDA & NME First-Cycle Success Rates and Trends.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c42984) has announced the addition of The US Drug Approval Trends and Yearbook 2006/2007 to their offering. Finally a comprehensive source for the very latest performance metrics Performance metrics are measures of an organizations activities and performance. Performance metrics should support a range of stakeholder needs from customers, shareholders to employees [1]. and trend analysis on every key aspect of the new drug approval process - The US Drug Approval Trends and Yearbook 2006/2007! In this first-of-its-kind compendium com·pen·di·um n. pl. com·pen·di·ums or com·pen·di·a 1. A short, complete summary; an abstract. 2. A list or collection of various items. , we examine hundreds of key trends and metrics metrics Managed care A popular term for standards by which the quality of a product, service, or outcome of a particular form of Pt management is evaluated. See TQM. to provide industry with all-new benchmarks and metrics on which to assess their own performance, to plan their own R&D projects, and to assess the various drug approval options and strategies available to them. The US Drug Approval Trends and Yearbook 2006/2007 provides an unprecedented number of in-depth analyses and benchmarks, including the following: * NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any and NME NME Name NME Enemy NME New Musical Express NME Neisseria Meningitidis NME New Molecular Entities (US FDA New Drug Approval reports) NME Network Management Ethernet NME New Music Express first-cycle success rates, review outcomes, and trends * Complete review and approval profiles for each NME and NDA, including cycles to approval, review times, and review outcomes * Analysis of drug review times, review cycle outcomes and success rates by therapeutic category and standard vs. priority classification * NDA and NME cycles to approval and review times through mid-2006 * The impact of priority review, fast track, accelerated approval, orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status and related programs on review times and review outcomes * Review outcomes, review times, and success rates for other key new drug submissions, including NDA resubmissions, efficacy supplements, and manufacturing supplements Based on data compiled through internal studies, Freedom of Information requests to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , and other public and private sources, our proprietary analyses will provide you with unique insights, benchmarks, and performance metrics in areas critical to the success of your R&D projects. For more information visit http://www.researchandmarkets.com/reports/c42984 |
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