Request for benefit-risk assessment addendum
Correspondence from ANMAT regarding ANMAT-2020-0095. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-195
Type
query
Application
Authority
ANMAT
Category
Administrative
Risk
Medium
Due Date
2025-03-02
Status
Draft
Owner
James O'Brien
Created
2024-02-25
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0095, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_195_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-02 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.