Request for benefit-risk assessment addendum
Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0011. Type: query. Risk: high. Category: Clinical.
Correspondence ID
COR-111
Type
query
Application
Authority
Taiwan Food and Drug Administration
Category
Clinical
Risk
High
Due Date
2025-02-04
Status
Draft
Owner
Marcus Webb
Created
2023-09-12
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
Attachments
study_report_111.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.