Request for benefit-risk assessment addendum
Correspondence from Health Sciences Authority regarding HSA-2023-0052. Type: information-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-052
Type
information-request
Application
Authority
Health Sciences Authority
Category
Nonclinical
Risk
Medium
Due Date
2025-01-05
Status
Open
Owner
Dmitri Volkov
Created
2023-03-04
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0052, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_52_1.pdfdata_table_52.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.