Deficiency: inadequate paediatric data justification
Correspondence from Health Sciences Authority regarding HSA-2023-0092. Type: information-request. Risk: low. Category: Administrative.
Correspondence ID
COR-192
Type
information-request
Application
Authority
Health Sciences Authority
Category
Administrative
Risk
Low
Due Date
2025-03-07
Status
Overdue
Owner
Sarah Chen
Created
2022-05-03
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0092, 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_192.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.