Request for post-marketing commitment progress update
Correspondence from ANMAT regarding ANMAT-2020-0075. Type: information-request. Risk: low. Category: Quality.
Correspondence ID
COR-375
Type
information-request
Application
Authority
ANMAT
Category
Quality
Risk
Low
Due Date
2024-12-13
Status
Draft
Owner
Dmitri Volkov
Created
2023-02-17
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0075, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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: 2024-12-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.