Deficiency: inadequate paediatric data justification
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0036. Type: information-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-036
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Administrative
Risk
Medium
Due Date
2025-03-12
Status
Overdue
Owner
Nadia Petrova
Created
2024-01-07
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0036, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change 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_36.pdfdata_table_36.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.