Request for additional clinical data on primary endpoint
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0010. Type: deficiency. Risk: medium. Category: Quality.
Correspondence ID
COR-510
Type
deficiency
Application
Authority
Ministry of Food and Drug Safety
Category
Quality
Risk
Medium
Due Date
2025-03-26
Status
Open
Owner
Lieselotte van der Berg
Created
2023-11-16
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0010, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_510.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.