Query: container closure integrity study methodology
Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0078. Type: question. Risk: low. Category: Clinical.
Correspondence ID
COR-578
Type
question
Application
Authority
South African Health Products Regulatory Authority
Category
Clinical
Risk
Low
Due Date
2025-04-20
Status
Draft
Owner
Dmitri Volkov
Created
2023-03-30
Correspondence Body
Dear SAHPRA Review Team,
With reference to application SAHPRA-2022-0078, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_578_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.