Request for additional clinical data on primary endpoint

Correspondence from Food and Drug Administration regarding FDA-2024-0021. Type: commitment-request. Risk: low. Category: Administrative.

Correspondence ID
COR-321
Type
commitment-request
Application
FDA-2024-0021
Authority
Food and Drug Administration
Category
Administrative
Risk
Low
Due Date
2024-12-26
Status
In Progress
Owner
Lieselotte van der Berg
Created
2024-01-23
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0021, 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
Attachments
data_table_321.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.