Deficiency letter: missing stability data for 40°C condition
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0080. Type: question. Risk: medium. Category: Clinical.
Correspondence ID
COR-380
Type
question
Application
Authority
Israel Ministry of Health
Category
Clinical
Risk
Medium
Due Date
2025-03-24
Status
Overdue
Owner
James O'Brien
Created
2023-07-30
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0080, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_380_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.