Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0077. Type: information-request. Risk: medium. Category: Labeling.

Correspondence ID
COR-077
Type
information-request
Application
Authority
Saudi Food and Drug Authority
Category
Labeling
Risk
Medium
Due Date
2025-01-08
Status
Draft
Owner
Tomoko Ikeda
Created
2023-04-12
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0077, we wish to address the following: [Detailed response body regarding request for post-marketing commitment progress update] 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: 2025-01-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.