Request for additional clinical data on primary endpoint

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0051. Type: commitment-request. Risk: high. Category: Administrative.

Correspondence ID
COR-151
Type
commitment-request
Application
TFDA-2024-0051
Authority
Taiwan Food and Drug Administration
Category
Administrative
Risk
High
Due Date
2025-04-25
Status
Draft
Owner
James O'Brien
Created
2023-07-14
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
Attachments
attachment_151_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.