Request for additional clinical data on primary endpoint

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0051. Type: query. Risk: medium. Category: Administrative.

Correspondence ID
COR-551
Type
query
Application
TFDA-2024-0051
Authority
Taiwan Food and Drug Administration
Category
Administrative
Risk
Medium
Due Date
2024-12-01
Status
Open
Owner
Marcus Webb
Created
2023-05-12
Correspondence Body
Dear TFDA Review Team, With reference to application TFDA-2024-0051, we wish to address the following: [Detailed response body regarding gmp inspection findings clarification] 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: 2024-12-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.