Deficiency: inadequate paediatric data justification
Correspondence from Health Canada regarding HC-2024-0066. Type: query. Risk: low. Category: Quality.
Correspondence ID
COR-466
Type
query
Application
Authority
Health Canada
Category
Quality
Risk
Low
Due Date
2025-03-03
Status
Overdue
Owner
Sarah Chen
Created
2022-12-18
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0066, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_466_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.