Query: container closure integrity study methodology
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0060. Type: question. Risk: low. Category: Clinical.
Correspondence ID
COR-260
Type
question
Application
Authority
Israel Ministry of Health
Category
Clinical
Risk
Low
Due Date
2025-01-27
Status
Open
Owner
Nadia Petrova
Created
2022-09-20
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 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.