Information request: extractables and leachables data

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0057. Type: commitment-request. Risk: medium. Category: Quality.

Correspondence ID
COR-357
Type
commitment-request
Application
SFDA-2023-0057
Authority
Saudi Food and Drug Authority
Category
Quality
Risk
Medium
Due Date
2025-01-15
Status
In Progress
Owner
Sarah Chen
Created
2022-11-22
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
Attachments
attachment_357_1.pdfdata_table_357.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.