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| 1983-2020年美国FDA认定身份及批准上市的孤儿药研究 |
| Orphan drug designation and approval trends in the United States from 1983 to 2020 |
| 投稿时间：2021-10-11 修订日期：2021-11-18 |
| DOI： |
| 中文关键词: FDA 孤儿药 审批 |
| 英文关键词: FDA Orphan drug approval |
| 基金项目:基于仿制药与原研药选择视角的医生处方行为影响因素与准实验干预研究 |
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| 中文摘要: |
| 目的：系统了解美国孤儿药批准情况,分析资格认定和审批趋势。方法：以美国食品药品监督管理局(FDA)数据库Drugs@ FDA和孤儿药资格认定和批准在线数据库为主要数据来源,系统收集美国FDA 1983至2020年获得资格认定和批准的孤儿药信息,从审批数量、审批时间、治疗领域等方面进行统计分析。结果：1983-2020年FDA共认定孤儿药资格5757个,批准孤儿药适应症943个。从孤儿药认定身份到获批上市平均所需的时间为5.14年。批准的孤儿药适应症中抗肿瘤和免疫机能调节相关适应症最多,为408个,占比为43.27%。结论：自1983年《孤儿药法案》实施以来,FDA授予的孤儿药资格数量和批准的孤儿药适应症数量呈现明显的增长趋势。 |
| 英文摘要: |
| Objective: To systematically describe U.S. Food and Drug Administration (FDA) approval status of orphan drugs, and to analyze trends of orphan drug designation and approval in the United States.Methods: We comprehensively explored FDA orphan drug designation and approval information from 1983 through 2020, using the Drugs@ FDA database and FDA Orphan Drug Product designation database. A statistical analysis was performed about the number of approved orphan drugs, approval time, and therapeutic areas. Results: From 1983 to 2020, FDA designated 5757 orphan drugs and approved 943 orphan drug indications. The average time required from orphan drug designation to market approval is 5.14 years. FDA approved 408 indications for antineoplastic and immunomodulatory therapy, namely 43.27% of approved indications, which was the most among all therapeutic areas. Conclusions: Since the implementation of the Orphan Drug Act, both the number of designated orphan drugs and the number of approved orphan drug indications have shown a significant growth trend. |
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