Information request: manufacturing process change justificat
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0060. Type: deficiency. Risk: low. Category: Clinical.
Correspondence ID
COR-460
Type
deficiency
Application
Authority
Israel Ministry of Health
Category
Clinical
Risk
Low
Due Date
2025-03-02
Status
Overdue
Owner
Priya Sharma
Created
2023-09-16
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: 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
study_report_460.pdfdata_table_460.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-02 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.