Deficiency letter: missing stability data for 40°C condition
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0016. Type: query. Risk: medium. Category: Labeling.
Correspondence ID
COR-216
Type
query
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Labeling
Risk
Medium
Due Date
2025-02-01
Status
Draft
Owner
Priya Sharma
Created
2023-03-04
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0016, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
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: 2025-02-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.