Query regarding bioequivalence study design

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0098. Type: question. Risk: medium. Category: Labeling.

Correspondence ID
COR-298
Type
question
Application
SAHPRA-2022-0098
Authority
South African Health Products Regulatory Authority
Category
Labeling
Risk
Medium
Due Date
2025-03-30
Status
In Progress
Owner
Dmitri Volkov
Created
2023-04-13
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0098, 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_298.xlsxstudy_report_298.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.