Request for additional clinical data on primary endpoint
Correspondence from COFEPRIS regarding COFEPRIS-2021-0074. Type: query. Risk: medium. Category: Clinical.
Correspondence ID
COR-374
Type
query
Application
Authority
COFEPRIS
Category
Clinical
Risk
Medium
Due Date
2025-02-27
Status
Draft
Owner
Tomoko Ikeda
Created
2022-09-12
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0074, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
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_374.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.