Request for post-marketing commitment progress update

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0038. Type: query. Risk: high. Category: Clinical.

Correspondence ID
COR-338
Type
query
Application
SAHPRA-2022-0038
Authority
South African Health Products Regulatory Authority
Category
Clinical
Risk
High
Due Date
2025-01-04
Status
Open
Owner
Nadia Petrova
Created
2024-02-25
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0038, 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
attachment_338_1.pdfstudy_report_338.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.