Request for updated SmPC section 4.1

Correspondence from Food and Drug Administration regarding FDA-2024-0041. Type: information-request. Risk: high. Category: Quality.

Correspondence ID
COR-241
Type
information-request
Application
FDA-2024-0041
Authority
Food and Drug Administration
Category
Quality
Risk
High
Due Date
2025-02-13
Status
In Progress
Owner
Nadia Petrova
Created
2023-11-11
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 post-marketing commitment progress update] 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: 2025-02-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.