Request for post-marketing commitment progress update
Correspondence from Health Canada regarding HC-2024-0026. Type: question. Risk: high. Category: Quality.
Correspondence ID
COR-026
Type
question
Application
Authority
Health Canada
Category
Quality
Risk
High
Due Date
2025-02-18
Status
In Progress
Owner
Sarah Chen
Created
2023-11-27
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0026, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_26.xlsxattachment_26_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-18 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.