BREAKTRHOUGH BIOTECHNOLOGIES: CAN THE FDA KEEP UP WITH THE SPEED OF SCIENCE?

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BREAKTRHOUGH BIOTECHNOLOGIES: CAN THE FDA KEEP UP WITH THE SPEED OF SCIENCE?

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Hong, Kristy en_US
dc.date.accessioned 2012-06-15T20:18:36Z
dc.date.issued 2004 en_US
dc.identifier.citation BREAKTRHOUGH BIOTECHNOLOGIES: CAN THE FDA KEEP UP WITH THE SPEED OF SCIENCE? (2004 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889444
dc.description.abstract Biotechnology advances have the potential to dramatically change the practice of medicine. Currently research is underway to find cures for diseases that were before untreatable, and many biotechnology products are already on the market improving the drugs and devices we use today. However, one important factor to ensure that the pace of biotechnology goes on unhindered is proper regulation. As the guardian of public health, the Food and Drug Administration has struggled to meet the demands of the rapidly growing field. In particular, the FDA has recognized three potential breakthrough areas of biotechnology that may need regulatory reform: cell and gene therapy, pharmacogenetics / pharmacogenomics, and novel drug delivery. This paper will examine the current state of these three technologies and the regulatory landscape surrounding them. 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 biotechnology en
dc.title BREAKTRHOUGH BIOTECHNOLOGIES: CAN THE FDA KEEP UP WITH THE SPEED OF SCIENCE? en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-15T20:18:36Z

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