Question on comparative dissolution data
Correspondence from Health Canada regarding HC-2024-0046. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-246
Type
question
Application
Authority
Health Canada
Category
Labeling
Risk
Medium
Due Date
2025-01-12
Status
In Progress
Owner
Carlos Mendez
Created
2022-06-29
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0046, 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_246.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.