Request for additional clinical data on primary endpoint

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

Correspondence ID
COR-041
Type
information-request
Application
FDA-2024-0041
Authority
Food and Drug Administration
Category
Nonclinical
Risk
Medium
Due Date
2025-04-21
Status
Completed
Owner
Tomoko Ikeda
Created
2023-06-25
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0041, we wish to address the following: [Detailed response body regarding query regarding bioequivalence study design] 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_41.xlsxattachment_41_1.pdf
Response Package
Response package assembled: RP-041