Information request: extractables and leachables data

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0098. Type: commitment-request. Risk: low. Category: Quality.

Correspondence ID
COR-498
Type
commitment-request
Application
SAHPRA-2022-0098
Authority
South African Health Products Regulatory Authority
Category
Quality
Risk
Low
Due Date
2025-01-31
Status
Open
Owner
Nadia Petrova
Created
2023-04-24
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0098, 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
study_report_498.pdfdata_table_498.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.