Question on comparative dissolution data
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0020. Type: query. Risk: high. Category: Quality.
Correspondence ID
COR-120
Type
query
Application
Authority
Israel Ministry of Health
Category
Quality
Risk
High
Due Date
2025-04-30
Status
In Progress
Owner
Dmitri Volkov
Created
2024-01-29
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 question on comparative dissolution data]
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_120.pdfattachment_120_1.pdf
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.