Deficiency: inadequate paediatric data justification
Correspondence from Health Canada regarding HC-2024-0046. Type: information-request. Risk: low. Category: Nonclinical.
Correspondence ID
COR-346
Type
information-request
Application
Authority
Health Canada
Category
Nonclinical
Risk
Low
Due Date
2025-04-24
Status
Overdue
Owner
Marcus Webb
Created
2023-10-10
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0046, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_346.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.