Information request: manufacturing process change justificat
Correspondence from Health Canada regarding HC-2024-0006. Type: query. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-206
Type
query
Application
Authority
Health Canada
Category
Nonclinical
Risk
Medium
Due Date
2025-01-25
Status
Draft
Owner
James O'Brien
Created
2022-08-17
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0006, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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_206.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.