Information request: manufacturing process change justificat

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0037. Type: information-request. Risk: medium. Category: Clinical.

Correspondence ID
COR-137
Type
information-request
Application
SFDA-2023-0037
Authority
Saudi Food and Drug Authority
Category
Clinical
Risk
Medium
Due Date
2024-12-01
Status
Overdue
Owner
Dmitri Volkov
Created
2023-01-03
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0037, 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
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.