Deficiency: inadequate paediatric data justification
Correspondence from Health Sciences Authority regarding HSA-2023-0072. Type: information-request. Risk: medium. Category: Quality.
Correspondence ID
COR-372
Type
information-request
Application
Authority
Health Sciences Authority
Category
Quality
Risk
Medium
Due Date
2024-12-26
Status
In Progress
Owner
Lieselotte van der Berg
Created
2023-12-04
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0072, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.