Correspondence from ANMAT regarding ANMAT-2020-0015. Type: question. Risk: high. Category: Quality.

Correspondence ID
COR-415
Type
question
Application
Authority
ANMAT
Category
Quality
Risk
High
Due Date
2025-04-12
Status
Draft
Owner
Aisha Okonkwo
Created
2022-10-28
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 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.