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Published on: July 22, 2010
Regulating Nanomedicine at the Food and Drug Administration
1Georgia Reithal Professor of Law at the Loyola University Chicago School of Law in Illinois, where she is also a faculty member in the Beazley Institute for Health Law and Policy, and served as a co-principal investigator on a National Science Foundation grant titled "NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context."
Abstract:
The US Food and Drug Administration (FDA) oversees safety and efficacy of a broad spectrum of medical products (ie, drugs, biologics, and devices) under the auspices of federal legislation and agency regulations and policy. Complex and emerging nanoscale products challenge this regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action. This article surveys current FDA regulatory structures and nanotechnology-specific guidance, discusses relevant nanomedicine products, and identifies regulatory challenges.
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