Request for updated SmPC section 4.1

Correspondence from Food and Drug Administration regarding FDA-2024-0061. Type: deficiency. Risk: low. Category: Administrative.

Correspondence ID
COR-261
Type
deficiency
Application
FDA-2024-0061
Authority
Food and Drug Administration
Category
Administrative
Risk
Low
Due Date
2025-02-15
Status
Draft
Owner
Tomoko Ikeda
Created
2023-07-20
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0061, we wish to address the following: [Detailed response body regarding deficiency: inadequate paediatric data justification] 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: 2025-02-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.