Deficiency letter: missing stability data for 40°C condition
Correspondence from Health Canada regarding HC-2024-0006. Type: query. Risk: high. Category: Nonclinical.
Correspondence ID
COR-106
Type
query
Application
Authority
Health Canada
Category
Nonclinical
Risk
High
Due Date
2025-01-27
Status
Draft
Owner
James O'Brien
Created
2024-02-10
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0006, 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
data_table_106.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.