Request for post-marketing commitment progress update

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0078. Type: query. Risk: low. Category: Nonclinical.

Correspondence ID
COR-478
Type
query
Application
SAHPRA-2022-0078
Authority
South African Health Products Regulatory Authority
Category
Nonclinical
Risk
Low
Due Date
2025-03-10
Status
Open
Owner
Lieselotte van der Berg
Created
2023-08-09
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 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.