Request for benefit-risk assessment addendum
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0065. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-465
Type
question
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Labeling
Risk
Medium
Due Date
2025-04-02
Status
Overdue
Owner
Carlos Mendez
Created
2023-02-04
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0065, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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: 2025-04-02 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.