Question on comparative dissolution data
Correspondence from Health Canada regarding HC-2024-0026. Type: commitment-request. Risk: high. Category: Labeling.
Correspondence ID
COR-226
Type
commitment-request
Application
Authority
Health Canada
Category
Labeling
Risk
High
Due Date
2025-03-27
Status
Draft
Owner
Priya Sharma
Created
2023-01-06
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
study_report_226.pdfdata_table_226.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.