Request for post-marketing commitment progress update
Correspondence from Health Canada regarding HC-2024-0066. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-266
Type
question
Application
Authority
Health Canada
Category
Labeling
Risk
Medium
Due Date
2025-01-10
Status
Open
Owner
Carlos Mendez
Created
2022-07-20
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0066, 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
data_table_266.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.