Request for benefit-risk assessment addendum

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0017. Type: question. Risk: high. Category: Labeling.

Correspondence ID
COR-317
Type
question
Application
SFDA-2023-0017
Authority
Saudi Food and Drug Authority
Category
Labeling
Risk
High
Due Date
2025-04-28
Status
In Progress
Owner
Carlos Mendez
Created
2024-03-06
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0017, we wish to address the following: [Detailed response body regarding request for additional clinical data on primary endpoint] 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_317.xlsxattachment_317_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-28 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.