Information request: extractables and leachables data
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0036. Type: information-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-136
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Clinical
Risk
Medium
Due Date
2025-02-05
Status
Draft
Owner
Priya Sharma
Created
2022-11-01
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0036, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_136_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.