Request for post-marketing commitment progress update
Correspondence from Health Sciences Authority regarding HSA-2023-0052. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-552
Type
query
Application
Authority
Health Sciences Authority
Category
Administrative
Risk
Medium
Due Date
2025-03-03
Status
In Progress
Owner
Tomoko Ikeda
Created
2024-02-18
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0052, 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
data_table_552.xlsxstudy_report_552.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.