Request for benefit-risk assessment addendum

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

Correspondence ID
COR-272
Type
query
Application
HSA-2023-0072
Authority
Health Sciences Authority
Category
Labeling
Risk
High
Due Date
2025-01-04
Status
Open
Owner
Sarah Chen
Created
2022-05-10
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
attachment_272_1.pdfstudy_report_272.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.