Query: container closure integrity study methodology

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0097. Type: query. Risk: high. Category: Nonclinical.

Correspondence ID
COR-597
Type
query
Application
SFDA-2023-0097
Authority
Saudi Food and Drug Authority
Category
Nonclinical
Risk
High
Due Date
2025-02-25
Status
Open
Owner
Nadia Petrova
Created
2023-12-14
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0097, we wish to address the following: [Detailed response body regarding request for additional clinical data on primary endpoint] 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_597.pdfattachment_597_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.