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- W1575804706 abstract "In the past, efforts to increase availability of new pharmaceutical products have focused on efficiencies in the regulatory process, such as streamlining data requirements, providing clear feedback on requirements for approval and shortening the review and approval process. Much progress has been made along those lines, but the changing economic environment has made those efforts alone to be inadequate. With the turn of the century, declining R&D productivity, greater concerns over risk, increased competition, industry consolidation, and pricing and reimbursement issues have dictated wider approaches to continued introduction of innovative products for treating human disease. Among these approaches are: earlier introduction of new products for limited indications, government incentives for private investment in research and encouraging innovative thinking in developing new research tools and methods, such as those being developed through the Critical Path Initiative. It is only through collaboration of industry, regulatory agency and academia that we can hope to return to the pharmaceutical innovation experienced over the last 40 years." @default.
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- W1575804706 date "2013-04-18" @default.
- W1575804706 modified "2023-10-14" @default.
- W1575804706 title "Future Prospects of the Pharmaceutical Industry and its Regulation in the USA" @default.
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- W1575804706 doi "https://doi.org/10.1002/9781118532331.ch26" @default.
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