Request for benefit-risk assessment addendum
Correspondence from COFEPRIS regarding COFEPRIS-2021-0074. Type: information-request. Risk: high. Category: Quality.
Correspondence ID
COR-074
Type
information-request
Application
Authority
COFEPRIS
Category
Quality
Risk
High
Due Date
2025-03-12
Status
Overdue
Owner
Sarah Chen
Created
2023-06-01
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
attachment_74_1.pdfdata_table_74.xlsx
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.