Request for benefit-risk assessment addendum
Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0038. Type: commitment-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-038
Type
commitment-request
Application
Authority
South African Health Products Regulatory Authority
Category
Clinical
Risk
Medium
Due Date
2025-01-02
Status
Open
Owner
Lieselotte van der Berg
Created
2023-07-10
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 benefit-risk assessment addendum]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_38.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-02 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.