Request for post-marketing commitment progress update
Correspondence from ANMAT regarding ANMAT-2020-0095. Type: deficiency. Risk: high. Category: Nonclinical.
Correspondence ID
COR-295
Type
deficiency
Application
Authority
ANMAT
Category
Nonclinical
Risk
High
Due Date
2025-01-16
Status
Overdue
Owner
Carlos Mendez
Created
2022-04-24
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0095, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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: 2025-01-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.