Query regarding bioequivalence study design

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0058. Type: question. Risk: high. Category: Clinical.

Correspondence ID
COR-058
Type
question
Application
SAHPRA-2022-0058
Authority
South African Health Products Regulatory Authority
Category
Clinical
Risk
High
Due Date
2024-12-17
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-05-26
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0058, we wish to address the following: [Detailed response body regarding information request: manufacturing process change justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_58_1.pdfstudy_report_58.pdf
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.