Deficiency letter: missing stability data for 40°C condition

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

Correspondence ID
COR-177
Type
question
Application
SFDA-2023-0077
Authority
Saudi Food and Drug Authority
Category
Labeling
Risk
Medium
Due Date
2025-04-06
Status
Draft
Owner
Priya Sharma
Created
2023-10-07
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0077, we wish to address the following: [Detailed response body regarding deficiency letter: missing stability data for 40°c condition] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
study_report_177.pdfdata_table_177.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.