Request for additional clinical data on primary endpoint
Correspondence from COFEPRIS regarding COFEPRIS-2021-0014. Type: deficiency. Risk: high. Category: Administrative.
Correspondence ID
COR-314
Type
deficiency
Application
Authority
COFEPRIS
Category
Administrative
Risk
High
Due Date
2025-02-23
Status
Draft
Owner
Dmitri Volkov
Created
2023-05-03
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0014, 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: 2025-02-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.