Request for updated SmPC section 4.1
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0031. Type: query. Risk: medium. Category: Quality.
Correspondence ID
COR-231
Type
query
Application
Authority
Taiwan Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2025-02-12
Status
Open
Owner
Priya Sharma
Created
2023-06-28
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0031, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
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: 2025-02-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.