Request for additional clinical data on primary endpoint

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0078. Type: information-request. Risk: medium. Category: Labeling.

Correspondence ID
COR-278
Type
information-request
Application
SAHPRA-2022-0078
Authority
South African Health Products Regulatory Authority
Category
Labeling
Risk
Medium
Due Date
2024-12-11
Status
Overdue
Owner
Marcus Webb
Created
2023-01-31
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0078, we wish to address the following: [Detailed response body regarding request for post-marketing commitment progress update] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.