Information request: manufacturing process change justificat
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0056. Type: information-request. Risk: high. Category: Nonclinical.
Correspondence ID
COR-556
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Nonclinical
Risk
High
Due Date
2025-01-14
Status
In Progress
Owner
Sarah Chen
Created
2023-02-15
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0056, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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_556.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.