Paradise, Jordan. (2010) Developing Oversight for Nanobiotechnology: Human Drugs and Medical Devices. [Video] (Unpublished)
Jordan_Paradise.mov - Presentation
Available under License Creative Commons Attribution No Derivatives.
The ability to utilize and control atoms and molecules at the nanoscale has catalyzed the emerging field of nanomedicine -- the application of nanotechnology to health and medicine. Nanotechnology and nanobiotechnology have the potential to provide tools for in vitro and in vivo diagnostics for much earlier detection of disease; facilitate targeted drug delivery and regenerative medical applications; supply anti-microbial coatings for implanted medical devices; and enable devices that seek, bind to, and destroy tumor cells. The Food and Drug Administration (FDA), the gatekeeper to clearance and approval of medical and health care products in the U.S., will be largely responsible for the oversight of the clinical research, approval and marketing of nanotechnology products. An inability to adequately regulate and monitor these technologies could have a substantial impact on public health; likewise, excessive regulation may ultimately hamper the development of valuable or even life-saving products. This presentation will present research findings that evaluate the current oversight of human drugs and medical devices by FDA and assess the application of these oversight frameworks to products of nanobiotechnology. The presentation will briefly examine issues of definition, product categorization, and U.S. oversight generally, and will then focus on specific challenges faced by the FDA regarding drug and medical device products at the nanoscale. I will be descriptive as to novel questions and potential gaps in the current regulatory structure, with some normative recommendations for evaluating these types of products in the future.
|Additional Information:||Emerging Organizations, Oversight, and Public Policy Systems|
|InterNano Taxonomy:||Social and Economic Impacts > Policy and Regulation
Environment, Health, and Safety > Epidemiology
|Collections:||Science Technology and Society's Nanotechnology and Society Workshops|
|Depositing User:||Michelle Sagan Goncalves|
|Date Deposited:||08 Nov 2010 15:06|
|Last Modified:||08 Nov 2010 15:06|
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