业界动态监管公开信息 · FDA
扩大获取 | 患者须知
FDA Drugs · 2026-10-30 02:11
摘要
扩大获取是一条途径，旨在尽早将有前景的医疗产品在药物和器械评估过程中提供给没有治疗选择的患者，这些患者要么已用尽获批疗法，要么无法耐受获批疗法，且无法参加临床试验。
English
Expanded Access | Information for Patients
Expanded access is a pathway designed to make promising medical products available as early in the drug and device evaluation process as possible to patients without therapeutic options, either because they have exhausted or are intolerant of approved therapies, and cannot enter a clinical trial.