“FDA每年只批2、3款基因疗法？这算失败！” ｜全球监管动态

▎药明康德内容团队编辑

参考资料：

[1] April 14, 2023: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement. Retrieved April 7, 2023, from https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-14-2023-joint-meeting-psychopharmacologic-drugs-advisory-committee-and-peripheral-and-central

[2] FDA closes out series of patient-focused drug development guidance. Retrieved April 7, 2023, from https://endpts.com/fda-closes-out-series-of-patient-focused-drug-development-guidance/

[3] 国家药监局药审中心关于发布《抗肿瘤抗体偶联药物临床研发技术指导原则》的通告（2023年第25号）. Retrieved April 7, 2023, from https://www.cde.org.cn/main/news/viewInfoCommon/24952a6fc17093a08aa81070a648c8c5

[4] 'Like salmon swimming upstream': FDA's Peter Marks lays out plan to boost gene therapy approvals. Retrieved April 7, 2023, from https://www.fiercebiotech.com/biotech/thats-failure-fdas-marks-says-gene-therapy-approvals-must-rapidly-increase