Deficiency letter: missing stability data for 40°C condition

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

Correspondence ID
COR-037
Type
information-request
Application
SFDA-2023-0037
Authority
Saudi Food and Drug Authority
Category
Labeling
Risk
Medium
Due Date
2025-03-21
Status
Open
Owner
Aisha Okonkwo
Created
2022-09-01
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0037, 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
Attachments
data_table_37.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.