Deficiency letter: missing stability data for 40°C condition

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0051. Type: deficiency. Risk: low. Category: Clinical.

Correspondence ID
COR-451
Type
deficiency
Application
TFDA-2024-0051
Authority
Taiwan Food and Drug Administration
Category
Clinical
Risk
Low
Due Date
2025-03-01
Status
Draft
Owner
Sarah Chen
Created
2022-10-26
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 additional clinical data on primary endpoint] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
study_report_451.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.