Request for additional clinical data on primary endpoint
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0090. Type: commitment-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-290
Type
commitment-request
Application
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
Medium
Due Date
2025-02-17
Status
Open
Owner
Carlos Mendez
Created
2023-03-02
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0090, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.