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Updated: May 12, 2025

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2019-2023年患者体验数据 (PED) 美国FDA NME药物批准:分析和建议

Jewell D Martin1, Darcy Frear2, Samantha A Roberts3,4

  • 1BioMarin (United States), San Rafael, CA, USA. jewell.martin@bmrn.com.

Therapeutic innovation & regulatory science
|May 9, 2025
PubMed
概括

患者体验数据 (PED) 越来越多地用于美国食品和药物管理局 (FDA) 的药物评价. 虽然在批准文件中包含的内容正在增加,但FDA在监管决策中如何考虑患者的观点需要更大的透明度.

关键词:
2019年2023年的时间.利与风险的关系在PED中,PED是PED,PED是PED患者体验数据 患者体验数据美国FDA美国FDA

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