Query: container closure integrity study methodology
Correspondence from Health Canada regarding HC-2024-0026. Type: information-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-126
Type
information-request
Application
Authority
Health Canada
Category
Administrative
Risk
Medium
Due Date
2025-04-16
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-12-03
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0026, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_126_1.pdfstudy_report_126.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.