Request for post-marketing commitment progress update
Correspondence from Health Sciences Authority regarding HSA-2023-0012. Type: question. Risk: medium. Category: Clinical.
Correspondence ID
COR-412
Type
question
Application
Authority
Health Sciences Authority
Category
Clinical
Risk
Medium
Due Date
2025-02-10
Status
Overdue
Owner
Marcus Webb
Created
2022-07-22
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0012, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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: 2025-02-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.