Information request: extractables and leachables data
Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0018. Type: deficiency. Risk: medium. Category: Quality.
Correspondence ID
COR-318
Type
deficiency
Application
Authority
South African Health Products Regulatory Authority
Category
Quality
Risk
Medium
Due Date
2025-04-25
Status
Overdue
Owner
Sarah Chen
Created
2023-04-30
Correspondence Body
Dear SAHPRA Review Team,
With reference to application SAHPRA-2022-0018, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data 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_318_1.pdfstudy_report_318.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.