Question on comparative dissolution data
Correspondence from Health Sciences Authority regarding HSA-2023-0072. Type: commitment-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-072
Type
commitment-request
Application
Authority
Health Sciences Authority
Category
Labeling
Risk
Medium
Due Date
2025-02-06
Status
In Progress
Owner
James O'Brien
Created
2023-05-23
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0072, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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: 2025-02-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.