申请企业

BLUEPRINT MEDICINES CORP

药品名称

GAVRETO (pralsetinib) 400 mg (once daily)

状态

未解决

承诺描述

Submit a summary of the final report of an analytical and clinical validation study, using clinical trial data, that is adequate to support labeling of an in vitro diagnostic device that demonstrates the device is essential to the safe and effective use of pralsetinib for patients with RET gene fusion thyroid cancers and RET-mutation-positive medullary thyroid cancer. The results of the validation study may inform product labeling.

承诺状态描述

报告接收日期

批准日期

2020/12/1 0:00:00

截止日期

2024/1/31 0:00:00

CDER/CBER

CD

子类型标记