Question on comparative dissolution data
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0080. Type: deficiency. Risk: medium. Category: Quality.
Correspondence ID
COR-580
Type
deficiency
Application
Authority
Israel Ministry of Health
Category
Quality
Risk
Medium
Due Date
2025-01-22
Status
Open
Owner
Aisha Okonkwo
Created
2022-12-16
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0080, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.