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  1.  76
    Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field.Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nancy M. P. King, Efrosini Kokkoli, Gary Marchant, Andrew D. Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A. Siegel & Samuel Wickline - 2012 - Journal of Law, Medicine and Ethics 40 (4):716-750.
    Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...)
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  2.  29
    Developing U.S. Oversight Strategies for Nanobiotechnology: Learning From Past Oversight Experiences.Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Aliya Kuzhabekova, Alison W. Tisdale, Efrosini Kokkoli & Gurumurthy Ramachandran - 2009 - Journal of Law, Medicine and Ethics 37 (4):688-705.
    The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past oversight efforts aimed at (...)
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  3.  12
    Review of the OSHA Framework for Oversight of Occupational Environments. [REVIEW]Jae-Young Choi & Gurumurthy Ramachandran - 2009 - Journal of Law, Medicine and Ethics 37 (4):633-650.
    Nanotechnology is a collection of different technologies and approaches dealing with manipulating matter with dimensions on the nanometer scale. The growth of nanotechnology has been rapid in recent years and encompasses a range of industries including pharmaceuticals, chemicals, robotics, medicine, agriculture, electronics, national defense, fiber optics, and energy. Nanoparticles with shapes, morphologies, and chemical compositions engineered for specific functions and applications are now common. While estimates of the numbers of new types of nanoparticles being produced in academic and industrial labs (...)
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  4.  19
    Review of the OSHA Framework for Oversight of Occupational Environments. [REVIEW]Jae-Young Choi & Gurumurthy Ramachandran - 2009 - Journal of Law, Medicine and Ethics 37 (4):633-650.
    The OSHA system for oversight of chemicals in the workplace was evaluated to derive lessons for oversight of nanotechnology. Criteria relating to the development, attributes, evolution, and outcomes of the system were used for evaluation that was based upon quantitative expert elicitation and historical literature analysis. The oversight system had inadequate resources in terms of finances, expertise, and personnel, and insufficient incentive for compliance. The system showed a lack of flexibility in novel situations. There were minimal requirements on companies for (...)
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  5.  17
    Handling Worker and Third-Party Exposures to Nanotherapeutics During Clinical Trials.Gurumurthy Ramachandran, John Howard, Andrew Maynard & Martin Philbert - 2012 - Journal of Law, Medicine and Ethics 40 (4):856-864.
    Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. (...)
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  6.  20
    Handling Worker and Third-Party Exposures to Nanotherapeutics During Clinical Trials.Gurumurthy Ramachandran, John Howard, Andrew Maynard & Martin Philbert - 2012 - Journal of Law, Medicine and Ethics 40 (4):856-864.
    The article focuses on issues relating to occupational exposures of researchers and lab workers, and exposures of bystanders such as health care workers and family members during HSR using nanomaterials. Such third-party exposures give rise to unique challenges relating to oversight as well as exposures to worker groups not previously studied. Given the current state of knowledge regarding health risks from such exposures, a more precautionary approach to oversight seems advisable.
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  7.  16
    Introduction.Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Gurumurthy Ramachandran & Efrosini Kokkoli - 2009 - Journal of Law, Medicine and Ethics 37 (4):543-545.
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  8.  6
    The Challenge of Developing Oversight Approaches to Nanobiotechnology.Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Gurumurthy Ramachandran & Efrosini Kokkoli - 2009 - Journal of Law, Medicine and Ethics 37 (4):543-545.
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