Request for benefit-risk assessment addendum
Correspondence from ANMAT regarding ANMAT-2020-0015. Type: query. Risk: high. Category: Nonclinical.
Correspondence ID
COR-215
Type
query
Application
Authority
ANMAT
Category
Nonclinical
Risk
High
Due Date
2025-01-08
Status
In Progress
Owner
Carlos Mendez
Created
2022-04-27
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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.