Question on comparative dissolution data
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0071. Type: question. Risk: low. Category: Quality.
Correspondence ID
COR-071
Type
question
Application
Authority
Taiwan Food and Drug Administration
Category
Quality
Risk
Low
Due Date
2025-01-03
Status
Open
Owner
Aisha Okonkwo
Created
2023-12-22
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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.