THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY

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THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Stepp, David L. en_US
dc.date.accessioned 2012-07-06T20:33:58Z
dc.date.issued 1999 en_US
dc.identifier.citation THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY (1999 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8965554
dc.description.abstract This paper attempts to provide a chronological history of the significant events and influences that have shaped the regulation of biotechnology by the Federal Food and Drug Administration. This paper first chronicles the evolution of each of the separate fields of regulation into which biological products are categorized by the FDA (drugs, biologics, devices, and foods). Part III of this paper then discusses the first call for governmental regulation of biotechnology and the struggle for regulatory form that this shift in administrative authority created. Part IV describes the Coordinated Framework for the Regulation of Biotechnology. Part V discusses subsequent efforts, both Congressional and administrative, to reform the regulation of biotechnology by FDA. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject FDA en
dc.subject regulation en
dc.subject biotechnology en
dc.subject drugs en
dc.subject biologics en
dc.subject devices en
dc.subject foods en
dc.title THE HISTORY OF FDA REGULATION OF BIOTECHNOLOGY IN THE TWENTIETH CENTURY en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-07-06T20:33:58Z

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