Request for post-marketing commitment progress update

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0017. Type: query. Risk: low. Category: Quality.

Correspondence ID
COR-117
Type
query
Application
SFDA-2023-0017
Authority
Saudi Food and Drug Authority
Category
Quality
Risk
Low
Due Date
2025-03-03
Status
Completed
Owner
Sarah Chen
Created
2022-09-17
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0017, 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_117.pdfdata_table_117.xlsx
Response Package
Response package assembled: RP-117