Request for benefit-risk assessment addendum
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0031. Type: information-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-531
Type
information-request
Application
Authority
Taiwan Food and Drug Administration
Category
Clinical
Risk
Medium
Due Date
2024-12-30
Status
In Progress
Owner
Nadia Petrova
Created
2023-03-16
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0031, 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
attachment_531_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.