Request for additional clinical data on primary endpoint
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0071. Type: commitment-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-271
Type
commitment-request
Application
Authority
Taiwan Food and Drug Administration
Category
Labeling
Risk
Medium
Due Date
2024-12-11
Status
Open
Owner
James O'Brien
Created
2023-11-03
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0071, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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: 2024-12-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.