Query regarding bioequivalence study design

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0058. Type: information-request. Risk: medium. Category: Administrative.

Correspondence ID
COR-358
Type
information-request
Application
SAHPRA-2022-0058
Authority
South African Health Products Regulatory Authority
Category
Administrative
Risk
Medium
Due Date
2025-04-11
Status
In Progress
Owner
Lieselotte van der Berg
Created
2022-08-18
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0058, 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
data_table_358.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.