Request for additional clinical data on primary endpoint

Correspondence from COFEPRIS regarding COFEPRIS-2021-0034. Type: commitment-request. Risk: high. Category: Administrative.

Correspondence ID
COR-534
Type
commitment-request
Application
COFEPRIS-2021-0034
Authority
COFEPRIS
Category
Administrative
Risk
High
Due Date
2025-04-16
Status
Open
Owner
Aisha Okonkwo
Created
2023-08-14
Correspondence Body
Dear COFEPRIS Review Team, With reference to application COFEPRIS-2021-0034, we wish to address the following: [Detailed response body regarding request for additional clinical data on primary endpoint] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
study_report_534.pdfattachment_534_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.