Request for additional clinical data on primary endpoint
Correspondence from COFEPRIS regarding COFEPRIS-2021-0094. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-194
Type
query
Application
Authority
COFEPRIS
Category
Administrative
Risk
Medium
Due Date
2025-03-12
Status
Open
Owner
Carlos Mendez
Created
2022-08-21
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0094, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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: 2025-03-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.