美国食品药品监督管理局对纳米医学的监管

Regulating Nanomedicine at the Food and Drug Administration.

作者信息

Paradise Jordan

机构信息

Georgia 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."

出版信息

AMA J Ethics. 2019 Apr 1;21(4):E347-355. doi: 10.1001/amajethics.2019.347.

DOI:10.1001/amajethics.2019.347

PMID:31012422

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.

摘要

美国食品药品监督管理局（FDA）在联邦立法以及机构法规和政策的支持下，负责监管各类医疗产品（即药品、生物制品和器械）的安全性和有效性。复杂且新兴的纳米级产品对这一监管框架构成了挑战，并凸显了其在整合多种治疗作用机制的组合产品方面的不足之处。本文概述了FDA当前的监管结构和针对纳米技术的指南，讨论了相关的纳米医学产品，并确定了监管方面的挑战。