Request for benefit-risk assessment addendum
Correspondence from Health Canada regarding HC-2024-0086. Type: question. Risk: low. Category: Clinical.
Correspondence ID
COR-186
Type
question
Application
Authority
Health Canada
Category
Clinical
Risk
Low
Due Date
2025-02-18
Status
Open
Owner
Marcus Webb
Created
2024-02-07
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0086, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
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_186.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-18 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.