Request for benefit-risk assessment addendum

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

Correspondence ID
COR-118
Type
query
Application
SAHPRA-2022-0018
Authority
South African Health Products Regulatory Authority
Category
Quality
Risk
Medium
Due Date
2024-12-17
Status
Draft
Owner
Priya Sharma
Created
2023-05-05
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0018, we wish to address the following: [Detailed response body regarding deficiency letter: missing stability data for 40°c condition] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_118_1.pdfdata_table_118.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.