Overview of FDA's Expanded Access Program for Investigational Drugs.
Overview of FDA's Expanded Access Program for Investigational Drugs.
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DOI：
10.1177/2168479017694850
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发表时间：
2017-03-01
影响因子：
1.5
通讯作者：
Lemery S
中科院分区：
文献类型：
--
作者：
Jarow JP;Lurie P;Ikenberry SC;Lemery S
扩大使用范围，也称为“同情使用”，为患者提供了获得研究药物、生物制剂和医疗设备的途径，这些药物、生物制剂和医疗设备用于诊断、监测或治疗患有严重疾病或病症的患者，而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。美国食品和药物管理局 (FDA) 促进扩大准入流程；然而，获得研究性治疗方法不仅需要 FDA 的审查和授权，还需要包括制药公司和医疗保健提供者在内的其他各方的积极参与和合作，才能取得成功。
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.