申请企业

RHYTHM PHARMACEUTICALS INC

药品名称

Imcivree (setmelanotide)

状态

提交

承诺描述

Conduct adequate analytical and clinical validation testing to establish an in-vitro diagnostic device developed to accurately and reliably detect patients with variants in the POMC, PCSK1, and LEPR genes that may benefit from setmelanotide therapy. The clinical validation should be supported by a clinical bridging study comparing the in-vitro diagnostic device and the clinical trial enrollment assays.

承诺状态描述

报告接收日期

批准日期

2020/11/25 0:00:00

截止日期

2020/11/30 0:00:00

CDER/CBER

CD

子类型标记