Deficiency: inadequate paediatric data justification
Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0058. Type: commitment-request. Risk: medium. Category: Quality.
Correspondence ID
COR-258
Type
commitment-request
Application
Authority
South African Health Products Regulatory Authority
Category
Quality
Risk
Medium
Due Date
2024-12-24
Status
Open
Owner
Sarah Chen
Created
2022-11-09
Correspondence Body
Dear SAHPRA Review Team,
With reference to application SAHPRA-2022-0058, we wish to address the following:
[Detailed response body regarding information request: manufacturing process change 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_258.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.