Request for benefit-risk assessment addendum
Correspondence from ANMAT regarding ANMAT-2020-0015. Type: deficiency. Risk: high. Category: Nonclinical.
Correspondence ID
COR-315
Type
deficiency
Application
Authority
ANMAT
Category
Nonclinical
Risk
High
Due Date
2025-01-19
Status
Overdue
Owner
Nadia Petrova
Created
2023-02-21
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0015, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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_315.pdfdata_table_315.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.