Information request: manufacturing process change justificat
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0096. Type: commitment-request. Risk: medium. Category: Quality.
Correspondence ID
COR-096
Type
commitment-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Quality
Risk
Medium
Due Date
2025-01-05
Status
Completed
Owner
Marcus Webb
Created
2023-05-20
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0096, 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
Response Package
Response package assembled: RP-096