Request for benefit-risk assessment addendum
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0030. Type: question. Risk: high. Category: Quality.
Correspondence ID
COR-330
Type
question
Application
Authority
Ministry of Food and Drug Safety
Category
Quality
Risk
High
Due Date
2025-04-30
Status
Overdue
Owner
Dmitri Volkov
Created
2023-07-31
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0030, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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_330.pdfdata_table_330.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.