Request for post-marketing commitment progress update

Correspondence from Food and Drug Administration regarding FDA-2024-0061. Type: question. Risk: medium. Category: Nonclinical.

Correspondence ID
COR-161
Type
question
Application
FDA-2024-0061
Authority
Food and Drug Administration
Category
Nonclinical
Risk
Medium
Due Date
2025-03-20
Status
Overdue
Owner
Aisha Okonkwo
Created
2023-10-13
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0061, we wish to address the following: [Detailed response body regarding request for updated smpc section 4.1] 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_161.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.