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Introduction to the U.S. FDA's "Good Abbreviated New Drug Application Assessment Practices" and reflections thereof
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Shao-rong WANG, Jun-lin ZHANG, Yu BAI
Chinese Journal of New Drugs | 2023, 32(20) : 2039 - 2043
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Chinese Journal of New Drugs | 2023, 32(20): 2039-2043
Introduction to the U.S. FDA's "Good Abbreviated New Drug Application Assessment Practices" and reflections thereof
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Shao-rong WANG, Jun-lin ZHANG, Yu BAI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100163, China
Published: 2023-10-30
Outline
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The U.S. Food and Drug Administration (FDA) has issued a series of policy documents in recent years to accelerate the approval and marketing of generic drugs. This article briefly introduced the relevant contents of one of these documents, i.e., "Good Abbreviated New Drug Application Assessment Practices", to explain how the US FDA tries to find a way, from the agency's perspective, to standardize the review process of generic drugs, and improve the review efficiency and effectiveness to promote generic drug marketing without quality compromising. Also, some thoughts were put forward respecting the relevant policies for the reform of China's drug review and approval system.

generic drug  /  drug evaluation  /  Good Assessment Practices  /  the reform of China's drug review and approval system
Shao-rong WANG, Jun-lin ZHANG, Yu BAI. Introduction to the U.S. FDA's "Good Abbreviated New Drug Application Assessment Practices" and reflections thereof[J]. Chinese Journal of New Drugs, 2023 , 32 (20) : 2039 -2043 .
Year 2023 volume 32 Issue 20
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Article Info
  • Online Date:2026-03-05
  • Published:2023-10-30
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History
  • Accepted:2023-06-08
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100163, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
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占总种数比例
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种数
Number of
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Percentage of total
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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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