Information request: manufacturing process change justificat
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0030. Type: deficiency. Risk: low. Category: Clinical.
Correspondence ID
COR-130
Type
deficiency
Application
Authority
Ministry of Food and Drug Safety
Category
Clinical
Risk
Low
Due Date
2025-03-06
Status
Open
Owner
Nadia Petrova
Created
2023-10-13
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0030, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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_130.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.