Information request: manufacturing process change justificat
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0050. Type: commitment-request. Risk: low. Category: Clinical.
Correspondence ID
COR-350
Type
commitment-request
Application
Authority
Ministry of Food and Drug Safety
Category
Clinical
Risk
Low
Due Date
2025-01-29
Status
Open
Owner
Sarah Chen
Created
2022-11-13
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0050, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_350.pdfattachment_350_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-29 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.