Deficiency letter: missing stability data for 40°C condition
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0016. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-416
Type
question
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Nonclinical
Risk
Medium
Due Date
2025-02-08
Status
Overdue
Owner
Aisha Okonkwo
Created
2023-12-23
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0016, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_416_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.