Information request: extractables and leachables data
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0056. Type: question. Risk: high. Category: Quality.
Correspondence ID
COR-356
Type
question
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Quality
Risk
High
Due Date
2025-01-29
Status
Overdue
Owner
Lieselotte van der Berg
Created
2023-02-11
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0056, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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: 2025-01-29 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.