Deficiency: inadequate paediatric data justification
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0020. Type: query. Risk: medium. Category: Quality.
Correspondence ID
COR-420
Type
query
Application
Authority
Israel Ministry of Health
Category
Quality
Risk
Medium
Due Date
2024-12-30
Status
Overdue
Owner
James O'Brien
Created
2023-11-07
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0020, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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_420.xlsxstudy_report_420.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.