Deficiency letter: missing stability data for 40°C condition
Correspondence from Health Canada regarding HC-2024-0046. Type: information-request. Risk: low. Category: Labeling.
Correspondence ID
COR-446
Type
information-request
Application
Authority
Health Canada
Category
Labeling
Risk
Low
Due Date
2025-04-24
Status
Overdue
Owner
Priya Sharma
Created
2023-07-27
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0046, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.