Deficiency letter: missing stability data for 40°C condition

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0037. Type: query. Risk: medium. Category: Quality.

Correspondence ID
COR-437
Type
query
Application
SFDA-2023-0037
Authority
Saudi Food and Drug Authority
Category
Quality
Risk
Medium
Due Date
2025-01-12
Status
Open
Owner
Aisha Okonkwo
Created
2022-10-29
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0037, we wish to address the following: [Detailed response body regarding query regarding bioequivalence study design] 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: 2025-01-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.