Deficiency letter: missing stability data for 40°C condition
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0076. Type: information-request. Risk: low. Category: Clinical.
Correspondence ID
COR-076
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Clinical
Risk
Low
Due Date
2025-02-15
Status
Open
Owner
Priya Sharma
Created
2022-12-09
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0076, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.