Economics of New Oncology Drug Development
作者： Joseph A. DiMasi , Henry G. Grabowski
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摘要: Purpose Review existing studies and provide new results on the development, regulatory, market aspects of oncology drug development. Methods We utilized data from US Food Drug Administration (FDA), company surveys, publicly available commercial business intelligence databases drugs approved in United States investigational to estimate average development regulatory approval times, clinical success rates, first-in-class status, global diffusion. Results found that have a disproportionately high share FDA priority review ratings, orphan designations at approval, were granted inclusion least one FDA's expedited access programs. times shorter, average, for (0.5 years), but longer (1.5 years). Clinical rates similar other ...
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