Query regarding bioequivalence study design
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0020. Type: commitment-request. Risk: low. Category: Nonclinical.
Correspondence ID
COR-220
Type
commitment-request
Application
Authority
Israel Ministry of Health
Category
Nonclinical
Risk
Low
Due Date
2025-04-26
Status
Open
Owner
Aisha Okonkwo
Created
2022-07-19
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 information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_220.xlsxstudy_report_220.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.