Request for additional clinical data on primary endpoint
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0051. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-051
Type
deficiency
Application
Authority
Taiwan Food and Drug Administration
Category
Labeling
Risk
Medium
Due Date
2025-03-20
Status
Completed
Owner
Nadia Petrova
Created
2023-10-11
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0051, 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 Package
Response package assembled: RP-051