Query regarding bioequivalence study design
Correspondence from Health Canada regarding HC-2024-0026. Type: commitment-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-326
Type
commitment-request
Application
Authority
Health Canada
Category
Nonclinical
Risk
Medium
Due Date
2025-05-01
Status
In Progress
Owner
Marcus Webb
Created
2022-05-05
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0026, 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
attachment_326_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-05-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.