Deficiency: inadequate paediatric data justification
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0040. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-340
Type
query
Application
Authority
Israel Ministry of Health
Category
Administrative
Risk
Medium
Due Date
2025-04-30
Status
Open
Owner
Dmitri Volkov
Created
2022-05-23
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 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: 2025-04-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.