Request for benefit-risk assessment addendum
Correspondence from Health Canada regarding HC-2024-0026. Type: information-request. Risk: medium. Category: Quality.
Correspondence ID
COR-426
Type
information-request
Application
Authority
Health Canada
Category
Quality
Risk
Medium
Due Date
2025-04-05
Status
Draft
Owner
Carlos Mendez
Created
2023-07-08
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0026, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_426_1.pdfstudy_report_426.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.