Query regarding bioequivalence study design

Correspondence from Taiwan Food and Drug Administration regarding TFDA-2024-0011. Type: commitment-request. Risk: low. Category: Administrative.

Correspondence ID
COR-011
Type
commitment-request
Application
TFDA-2024-0011
Authority
Taiwan Food and Drug Administration
Category
Administrative
Risk
Low
Due Date
2025-01-23
Status
Overdue
Owner
Tomoko Ikeda
Created
2023-09-16
Correspondence Body
Dear TFDA Review Team, With reference to application TFDA-2024-0011, we wish to address the following: [Detailed response body regarding request for benefit-risk assessment addendum] 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_11.pdfattachment_11_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.