Request for additional clinical data on primary endpoint

Correspondence from National Medical Products Administration regarding NMPA-2021-0024. Type: question. Risk: low. Category: Nonclinical.

Correspondence ID
COR-224
Type
question
Application
NMPA-2021-0024
Authority
National Medical Products Administration
Category
Nonclinical
Risk
Low
Due Date
2025-04-19
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-07-23
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0024, we wish to address the following: [Detailed response body regarding information request: extractables and leachables data] 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: 2025-04-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.