Deficiency letter: missing stability data for 40°C condition
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0056. Type: information-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-056
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Clinical
Risk
Medium
Due Date
2025-03-07
Status
Completed
Owner
Sarah Chen
Created
2022-08-01
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0056, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
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-056