Request for benefit-risk assessment addendum

Correspondence from National Medical Products Administration regarding NMPA-2021-0064. Type: commitment-request. Risk: high. Category: Labeling.

Correspondence ID
COR-164
Type
commitment-request
Application
NMPA-2021-0064
Authority
National Medical Products Administration
Category
Labeling
Risk
High
Due Date
2024-12-11
Status
Open
Owner
James O'Brien
Created
2023-04-29
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0064, we wish to address the following: [Detailed response body regarding request for additional clinical data on primary endpoint] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
study_report_164.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.