Oversight systems specific to nanotechnology have not yet been created; stakeholders, government, industry, academia, and the public are debating whether and how to craft such systems and address emerging safety, social, and ethical issues. The United States has no coordinated policy for oversight...

Federal oversight of nanobiotechnology in the United States has been fragmented and incremental. The prevailing approach (at FDA, OSHA, and other key agencies) has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach is...

Analysis of science and technology oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy,...

Nanotechnology expands across research domains, applications and products and remains a field with neither a single scientific definition nor a formal regulatory or statutory definition. However, health and medical applications are burgeoning. This article examines the field of nanomedicine in...

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout,...

Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). hese are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in...