Request for additional clinical data on primary endpoint
Correspondence from ANMAT regarding ANMAT-2020-0035. Type: information-request. Risk: high. Category: Quality.
Correspondence ID
COR-235
Type
information-request
Application
Authority
ANMAT
Category
Quality
Risk
High
Due Date
2025-01-27
Status
Draft
Owner
Aisha Okonkwo
Created
2023-10-03
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0035, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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_235.pdfdata_table_235.xlsx
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.