Request for benefit-risk assessment addendum
Correspondence from Health Sciences Authority regarding HSA-2023-0032. Type: information-request. Risk: high. Category: Administrative.
Correspondence ID
COR-432
Type
information-request
Application
Authority
Health Sciences Authority
Category
Administrative
Risk
High
Due Date
2025-04-17
Status
In Progress
Owner
Marcus Webb
Created
2022-09-12
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0032, 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_432.xlsxattachment_432_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.