Request for post-marketing commitment progress update
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0090. Type: deficiency. Risk: medium. Category: Labeling.
Correspondence ID
COR-190
Type
deficiency
Application
Authority
Ministry of Food and Drug Safety
Category
Labeling
Risk
Medium
Due Date
2024-12-20
Status
Open
Owner
Lieselotte van der Berg
Created
2024-02-13
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0090, 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
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.