Request for benefit-risk assessment addendum

Correspondence from National Medical Products Administration regarding NMPA-2021-0004. Type: query. Risk: medium. Category: Clinical.

Correspondence ID
COR-404
Type
query
Application
NMPA-2021-0004
Authority
National Medical Products Administration
Category
Clinical
Risk
Medium
Due Date
2025-01-24
Status
Open
Owner
Dmitri Volkov
Created
2023-11-25
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0004, we wish to address the following: [Detailed response body regarding deficiency: inadequate paediatric data justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.