Information request: extractables and leachables data
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0056. Type: information-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-156
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Labeling
Risk
Medium
Due Date
2025-01-05
Status
Draft
Owner
Marcus Webb
Created
2023-01-04
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
Attachments
attachment_156_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.