Deficiency letter: missing stability data for 40°C condition

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0018. Type: information-request. Risk: medium. Category: Quality.

Correspondence ID
COR-218
Type
information-request
Application
SAHPRA-2022-0018
Authority
South African Health Products Regulatory Authority
Category
Quality
Risk
Medium
Due Date
2024-12-26
Status
In Progress
Owner
Lieselotte van der Berg
Created
2023-02-15
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0018, 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
study_report_218.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.