Request for benefit-risk assessment addendum
Correspondence from COFEPRIS regarding COFEPRIS-2021-0054. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-354
Type
question
Application
Authority
COFEPRIS
Category
Nonclinical
Risk
Medium
Due Date
2025-04-07
Status
In Progress
Owner
Tomoko Ikeda
Created
2024-03-07
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0054, 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: 2025-04-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.