Request for benefit-risk assessment addendum
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0040. Type: question. Risk: high. Category: Quality.
Correspondence ID
COR-040
Type
question
Application
Authority
Israel Ministry of Health
Category
Quality
Risk
High
Due Date
2025-02-17
Status
Open
Owner
Dmitri Volkov
Created
2023-12-19
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0040, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_40.pdfattachment_40_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.