Information request: manufacturing process change justificat
Correspondence from Health Canada regarding HC-2024-0086. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-486
Type
question
Application
Authority
Health Canada
Category
Nonclinical
Risk
Medium
Due Date
2025-03-30
Status
In Progress
Owner
Aisha Okonkwo
Created
2024-02-02
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0086, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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_486.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.