Request for benefit-risk assessment addendum
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0011. Type: question. Risk: medium. Category: Quality.
Correspondence ID
COR-211
Type
question
Application
Authority
Taiwan Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2025-04-07
Status
Open
Owner
Carlos Mendez
Created
2022-05-18
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0011, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
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: 2025-04-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.