Question on comparative dissolution data
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0040. Type: commitment-request. Risk: low. Category: Quality.
Correspondence ID
COR-140
Type
commitment-request
Application
Authority
Israel Ministry of Health
Category
Quality
Risk
Low
Due Date
2024-12-22
Status
Overdue
Owner
Lieselotte van der Berg
Created
2023-08-04
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 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_140.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.