Request for additional clinical data on primary endpoint
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0076. Type: query. Risk: medium. Category: Labeling.
Correspondence ID
COR-176
Type
query
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Labeling
Risk
Medium
Due Date
2025-02-20
Status
Overdue
Owner
Aisha Okonkwo
Created
2023-03-26
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0076, 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
data_table_176.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.