Information request: manufacturing process change justificat

Correspondence from Food and Drug Administration regarding FDA-2024-0001. Type: deficiency. Risk: medium. Category: Quality.

Correspondence ID
COR-201
Type
deficiency
Application
FDA-2024-0001
Authority
Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2025-01-14
Status
Overdue
Owner
Tomoko Ikeda
Created
2023-08-29
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0001, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.