Information request: extractables and leachables data
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0096. Type: information-request. Risk: low. Category: Nonclinical.
Correspondence ID
COR-496
Type
information-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Nonclinical
Risk
Low
Due Date
2024-12-25
Status
Draft
Owner
James O'Brien
Created
2023-10-23
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0096, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_496.pdfattachment_496_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.