Query regarding bioequivalence study design
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0096. Type: deficiency. Risk: medium. Category: Clinical.
Correspondence ID
COR-396
Type
deficiency
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Clinical
Risk
Medium
Due Date
2025-04-29
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-10-23
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0096, 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
Attachments
data_table_396.xlsxstudy_report_396.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-29 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.