Current regulatory status in China of drugs withdrawn from the US FDA accelerated pathway: implications for regulation globally.

Luo, Xingxian; Huang, Lin; Du, Xin; Yang, Yue; Lv, Xufeng; Zhang, Xiaohong

Luo, Xingxian; Huang, Lin; Du, Xin; Yang, Yue; Lv, Xufeng; Zhang, Xiaohong.

Afiliação

Luo X; Department of Pharmacy, Peking University People's Hospital, Beijing 100000, China.
Huang L; Department of Pharmacy, Peking University People's Hospital, Beijing 100000, China.
Du X; Vanke School of Public Health, Tsinghua University, Beijing, China.
Yang Y; School of Pharmaceutical Sciences, Tsinghua University, Beijing, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing, China.
Lv X; Center for Drug Evaluation, National Medical Products Administration, Beijing, China.
Zhang X; Department of Pharmacy, Peking University People's Hospital, Beijing 100000, China. Electronic address: zhangxiaohong@pkuph.edu.cn.

Lancet Oncol ; 25(6): 703-706, 2024 Jun.

Article em En | MEDLINE | ID: mdl-38821082

Assuntos

United States Food and Drug Administration; United States Food and Drug Administration/legislação & jurisprudência; Estados Unidos; China; Humanos; Retirada de Medicamento Baseada em Segurança; Aprovação de Drogas/legislação & jurisprudência

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration Limite: Humans País/Região como assunto: America do norte / Asia Idioma: En Revista: Lancet Oncol Assunto da revista: NEOPLASIAS Ano de publicação: 2024 Tipo de documento: Article País de afiliação: China

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