Request for benefit-risk assessment addendum
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0051. Type: commitment-request. Risk: high. Category: Quality.
Correspondence ID
COR-251
Type
commitment-request
Application
Authority
Taiwan Food and Drug Administration
Category
Quality
Risk
High
Due Date
2025-01-22
Status
Draft
Owner
Marcus Webb
Created
2023-01-11
Correspondence Body
Dear TFDA Review Team,
With reference to application TFDA-2024-0051, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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_251.xlsxattachment_251_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.