Deficiency letter: missing stability data for 40°C condition
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0060. Type: commitment-request. Risk: high. Category: Quality.
Correspondence ID
COR-060
Type
commitment-request
Application
Authority
Israel Ministry of Health
Category
Quality
Risk
High
Due Date
2025-02-04
Status
Open
Owner
Dmitri Volkov
Created
2023-01-05
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 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.