A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China

Storm, NE; Chang, W; Lin, TC; Lange, JL; Bradbury, B; Critchlow, CW; Galson, SK

Storm, NE (通讯作者)，Amgen Inc, One Amgen Ctr Dr, Thousand Oaks, CA 91320 USA.;Storm, NE (通讯作者)，Univ Southern Calif, DK Kim Int Ctr Regulatory Sci, Sch Pharm, Dept Regulatory & Qual Sci, 1540 Alcazar St,CHP 140, Los Angeles, CA 90089 USA.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2022; 56 (1): 137

Abstract

On June 23, 2020, Prolia(R) (denosumab) was approved by the National Medical Products Administration (NMPA) in the People's Republic of China as the f......

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