Information request: manufacturing process change justificat
Correspondence from Health Canada regarding HC-2024-0066. Type: deficiency. Risk: medium. Category: Clinical.
Correspondence ID
COR-066
Type
deficiency
Application
Authority
Health Canada
Category
Clinical
Risk
Medium
Due Date
2025-01-21
Status
In Progress
Owner
Dmitri Volkov
Created
2023-11-24
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0066, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
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_66.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.