Request for post-marketing commitment progress update

Correspondence from Health Sciences Authority regarding HSA-2023-0072. Type: commitment-request. Risk: medium. Category: Labeling.

Correspondence ID
COR-172
Type
commitment-request
Application
HSA-2023-0072
Authority
Health Sciences Authority
Category
Labeling
Risk
Medium
Due Date
2025-03-26
Status
In Progress
Owner
James O'Brien
Created
2023-10-31
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 post-marketing commitment progress update] 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: 2025-03-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.