Request for post-marketing commitment progress update

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

Correspondence ID
COR-472
Type
information-request
Application
HSA-2023-0072
Authority
Health Sciences Authority
Category
Labeling
Risk
High
Due Date
2025-02-01
Status
Overdue
Owner
Sarah Chen
Created
2022-04-16
Correspondence Body
Dear HSA Review Team, With reference to application HSA-2023-0072, we wish to address the following: [Detailed response body regarding information request: manufacturing process change justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
data_table_472.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.