Question on comparative dissolution data
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0016. Type: query. Risk: medium. Category: Clinical.
Correspondence ID
COR-116
Type
query
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Clinical
Risk
Medium
Due Date
2025-03-27
Status
Draft
Owner
Sarah Chen
Created
2022-06-08
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
study_report_116.pdfattachment_116_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.