Information request: manufacturing process change justificat
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0056. Type: commitment-request. Risk: high. Category: Clinical.
Correspondence ID
COR-456
Type
commitment-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Clinical
Risk
High
Due Date
2025-02-12
Status
Open
Owner
Carlos Mendez
Created
2023-11-19
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0056, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_456.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.