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Incentive policy evaluation on orphan drugs in the United States during 1983—2019
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Jing-shu YANG1, 2, 3, Dian-zheng YANG1, 4, Yue YANG1, 2
Chinese Journal of New Drugs | 2021, 30(21) : 1921 - 1927
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Chinese Journal of New Drugs | 2021, 30(21): 1921-1927
Incentive policy evaluation on orphan drugs in the United States during 1983—2019
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Jing-shu YANG1, 2, 3, Dian-zheng YANG1, 4, Yue YANG1, 2
Affiliations
  • 1School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
  • 2Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China
  • 3Tsinghua-Peking Center for Life Sciences, Tsinghua University, Beijing 100084, China
  • 4School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
Published: 2021-11-15
Outline
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The incentive policy for orphan drugs was evaluated by statistical analysis of the R&D (research and development) and approval of orphan drugs in the United States during 1983—2019. The clinical trials funding, qualification and approval of orphan drugs were statistically analyzed by consulting the FDA official website, clinicaltrial.gov database and related literature. Since the implementation of the Orphan Drug Act in 1983, the United States has established a systematic R&D incentive system for orphan drugs up to now, which has played a huge role in promoting drug R&D and approval.

rare disease  /  orphan drug  /  research and development  /  review and approval  /  clinical trials
杨景舒, 杨殿政, 杨悦. 1983—2019年美国孤儿药激励政策评价. 中国新药杂志, 2021 , 30 (21) : 1921 -1927 .
Jing-shu YANG, Dian-zheng YANG, Yue YANG. Incentive policy evaluation on orphan drugs in the United States during 1983—2019[J]. Chinese Journal of New Drugs, 2021 , 30 (21) : 1921 -1927 .
Year 2021 volume 30 Issue 21
23
3
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  • Online Date:2026-10-30
  • Published:2021-11-15
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  • Accepted:2021-02-20
Affiliations
    1School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
    2Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China
    3Tsinghua-Peking Center for Life Sciences, Tsinghua University, Beijing 100084, China
    4School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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