Information request: manufacturing process change justificat
Correspondence from Health Sciences Authority regarding HSA-2023-0052. Type: commitment-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-452
Type
commitment-request
Application
Authority
Health Sciences Authority
Category
Administrative
Risk
Medium
Due Date
2025-01-17
Status
Overdue
Owner
Tomoko Ikeda
Created
2023-05-10
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0052, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.