Question on comparative dissolution data

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

Correspondence ID
COR-398
Type
question
Application
SAHPRA-2022-0098
Authority
South African Health Products Regulatory Authority
Category
Administrative
Risk
Medium
Due Date
2024-12-28
Status
Overdue
Owner
Sarah Chen
Created
2023-09-10
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0098, we wish to address the following: [Detailed response body regarding query regarding bioequivalence study design] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-28 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.