美国食品药品监督管理局（FDA）研究性药物扩大使用项目概述。
Overview of FDA's Expanded Access Program for Investigational Drugs.
作者信息
Jarow Jonathan P, Lurie Peter, Ikenberry Sarah Crowley, Lemery Steven
机构信息
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA.
出版信息
Ther Innov Regul Sci. 2017 Mar 1;51(2):177-179. doi: 10.1177/2168479017694850.
Abstract
Expanded access, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. The US Food and Drug Administration (FDA) facilitates the expanded access process; however, access to investigational treatments requires not only FDA's review and authorization but also the active involvement and cooperation of other parties, including drug companies and health care providers, in order to be successful.
摘要
扩大使用，也称为“同情用药”，为患者提供了一条途径，使其能够获得用于诊断、监测或治疗患有严重疾病或病症的患者的研究性药物、生物制品和医疗设备，而对于这些疾病或病症，在临床试验之外没有可比或令人满意的治疗选择。美国食品药品监督管理局（FDA）推动扩大使用的过程；然而，获得研究性治疗不仅需要FDA的审查和授权，还需要其他各方（包括制药公司和医疗服务提供者）的积极参与与合作才能成功。
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本文引用的文献
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The Ethical Challenges of Compassionate Use.同情用药的伦理挑战。
JAMA. 2016 Mar 8;315(10):979-80. doi: 10.1001/jama.2016.0416.
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Going "social" to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access.通过“社交”途径获取实验性且可能挽救生命的治疗：对扩大获取途径的政策及在线患者维权环境的评估
BMC Med. 2016 Feb 2;14:17. doi: 10.1186/s12916-016-0568-8.
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The strange allure of state "right-to-try" laws.州“尝试权”法律的奇特吸引力。
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