Request for benefit-risk assessment addendum

Correspondence from Food and Drug Administration regarding FDA-2024-0061. Type: commitment-request. Risk: medium. Category: Quality.

Correspondence ID
COR-461
Type
commitment-request
Application
FDA-2024-0061
Authority
Food and Drug Administration
Category
Quality
Risk
Medium
Due Date
2025-02-27
Status
Draft
Owner
Lieselotte van der Berg
Created
2023-09-02
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0061, we wish to address the following: [Detailed response body regarding gmp inspection findings clarification] 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: 2025-02-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.