Deficiency letter: missing stability data for 40°C condition

Correspondence from Food and Drug Administration regarding FDA-2024-0041. Type: query. Risk: medium. Category: Quality.

Correspondence ID
COR-341
Type
query
Application
FDA-2024-0041
Authority
Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2025-03-23
Status
Overdue
Owner
Carlos Mendez
Created
2023-12-10
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0041, 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
data_table_341.xlsxstudy_report_341.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.