Deficiency letter: missing stability data for 40°C condition

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0071. Type: commitment-request. Risk: medium. Category: Nonclinical.

Correspondence ID
COR-571
Type
commitment-request
Application
TFDA-2024-0071
Authority
Taiwan Food and Drug Administration
Category
Nonclinical
Risk
Medium
Due Date
2025-04-18
Status
In Progress
Owner
Tomoko Ikeda
Created
2022-10-10
Correspondence Body
Dear TFDA Review Team, With reference to application TFDA-2024-0071, 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
Attachments
data_table_571.xlsxstudy_report_571.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-18 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.