Deficiency letter: missing stability data for 40°C condition
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0060. Type: query. Risk: medium. Category: Clinical.
Correspondence ID
COR-360
Type
query
Application
Authority
Israel Ministry of Health
Category
Clinical
Risk
Medium
Due Date
2025-02-27
Status
Draft
Owner
Priya Sharma
Created
2024-01-11
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0060, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
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_360.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.