Deficiency: inadequate paediatric data justification
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0070. Type: deficiency. Risk: high. Category: Labeling.
Correspondence ID
COR-170
Type
deficiency
Application
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
High
Due Date
2024-12-17
Status
In Progress
Owner
Carlos Mendez
Created
2023-07-30
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0070, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_170.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.