{"title":"Fda New Drug Approval Times, Prescription Drug User Fees, and R&D Spending","authors":"J. Golec, J. Vernon, R. Lutter, C. Nardinelli","doi":"10.2139/ssrn.931153","DOIUrl":null,"url":null,"abstract":"FDA-approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical RD thus, the social benefits of PDUFA (over and above the benefits of more rapid consumer access) are likely to be substantial.","PeriodicalId":297504,"journal":{"name":"Legislation & Statutory Interpretation","volume":"9 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2006-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"9","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Legislation & Statutory Interpretation","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2139/ssrn.931153","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 9
Abstract
FDA-approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical RD thus, the social benefits of PDUFA (over and above the benefits of more rapid consumer access) are likely to be substantial.
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