Question on comparative dissolution data
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0036. Type: information-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-236
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Administrative
Risk
Medium
Due Date
2025-01-16
Status
Open
Owner
James O'Brien
Created
2022-07-09
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0036, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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: 2025-01-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.