Request for benefit-risk assessment addendum
Correspondence from Health Sciences Authority regarding HSA-2023-0012. Type: commitment-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-212
Type
commitment-request
Application
Authority
Health Sciences Authority
Category
Labeling
Risk
Medium
Due Date
2025-02-07
Status
Draft
Owner
Nadia Petrova
Created
2022-09-02
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 benefit-risk assessment addendum]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_212.pdfattachment_212_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.