Request for additional clinical data on primary endpoint

Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0008. Type: information-request. Risk: medium. Category: Quality.

Correspondence ID
COR-008
Type
information-request
Application
MHRA-2022-0008
Authority
Medicines and Healthcare products Regulatory Agency
Category
Quality
Risk
Medium
Due Date
2025-04-04
Status
In Progress
Owner
Priya Sharma
Created
2023-08-03
Correspondence Body
Dear MHRA Review Team, With reference to application MHRA-2022-0008, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] 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_8.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.