Deficiency letter: missing stability data for 40°C condition

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0057. Type: question. Risk: low. Category: Clinical.

Correspondence ID
COR-057
Type
question
Application
SFDA-2023-0057
Authority
Saudi Food and Drug Authority
Category
Clinical
Risk
Low
Due Date
2025-04-01
Status
Overdue
Owner
Carlos Mendez
Created
2023-08-30
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0057, we wish to address the following: [Detailed response body regarding deficiency: inadequate paediatric data justification] 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: 2025-04-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.