GMP inspection findings clarification
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0080. Type: query. Risk: low. Category: Clinical.
Correspondence ID
COR-280
Type
query
Application
Authority
Israel Ministry of Health
Category
Clinical
Risk
Low
Due Date
2025-01-04
Status
Draft
Owner
Aisha Okonkwo
Created
2022-10-13
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 query regarding bioequivalence study design]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_280_1.pdfstudy_report_280.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.