Question on comparative dissolution data
Correspondence from Health Canada regarding HC-2024-0046. Type: information-request. Risk: high. Category: Nonclinical.
Correspondence ID
COR-146
Type
information-request
Application
Authority
Health Canada
Category
Nonclinical
Risk
High
Due Date
2025-03-07
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-04-18
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0046, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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_146.xlsxstudy_report_146.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.