Information request: manufacturing process change justificat
Correspondence from Health Sciences Authority regarding HSA-2023-0092. Type: query. Risk: low. Category: Quality.
Correspondence ID
COR-392
Type
query
Application
Authority
Health Sciences Authority
Category
Quality
Risk
Low
Due Date
2025-02-03
Status
Overdue
Owner
Carlos Mendez
Created
2022-09-01
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0092, 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
Attachments
attachment_392_1.pdfstudy_report_392.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.