Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences

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For purposes of analysis, oversight of drugs and medical devices was analyzed in a single article due to commonalities between the two oversight systems at the U.S. Food and Drug Administration. Throughout this comparative article, we will refer to that single article as containing two case studies. Thus, there are a total of five case studies (oversight of GEOs, drugs, devices, workplace chemicals, and gene therapy).

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See FFDCA , supra note 32.

See Paradise , supra note 33, at 415–417.

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See Wolf Gupta Kohlhepp , supra note 6.

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See references to all case studies in this symposium, supra note 6.

The exact survey instrument and methodology employed for expert elicitation varied somewhat among the case studies, given the different subject matter. For specific information, refer to each case study in the symposium.

See Kuzma J. , “An Integrated Approach to Oversight Assessment for Emerging Technologies,” Risk Analysis 28, no. 4 (2008): 1197–1219.

See references to all case studies in this symposium, supra note 6.

Note that the case study on chemicals in the workplace used 26 criteria, not 28, as two of the oversight evaluation criteria were not germane.

For additional information and explanation, refer to the case studies in this symposium on drugs and medical devices, GEOs, and workplace chemicals, see supra note 6.

See, e.g., Morgan G. Henrion M. , Performing Probability Assessment in Uncertainty (Cambridge, U.K.: Cambridge University Press, 1990): At 141–171.

See references to all case studies in this symposium, supra note 6.

See Kuzma , supra note 44.

See references to all case studies in this symposium, supra note 6.

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See 21 C.F.R. 310.305; 21 C.F.R. 314.80 (2009).

See, e.g., 21 U.S.C. § 505(o)(4) regarding “new safety information” relevant to labeling. For a discussion of the impact of this provision, see Danzis S. D. Pitlyk S. E. , “FDAAA's Safety Labeling Provisions,” Food and Drug Law Institute Update Magazine, January/February 2009, at 10–13.

Wardak A. Gorman M. , “Using Trading Zones and Life Cycle Analysis to Understand Nanotechnology Regulation,” Journal of Law, Medicine & Ethics 34, no. 4 (2006): 695–703; Breggin Pendergrass , supra note 28.

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See Wardak Gorman , supra note 56.

See Choi Ramanchandran , supra note 6.

See Davies , Nanotechnology Oversight: An Agenda for the New Administration, supra note 28.

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