Deficiency letter: missing stability data for 40°C condition
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0011. Type: deficiency. Risk: medium. Category: Quality.
Correspondence ID
COR-411
Type
deficiency
Application
Authority
Taiwan Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2024-12-06
Status
Draft
Owner
Dmitri Volkov
Created
2023-07-28
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0011, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
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: 2024-12-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.