Deficiency: inadequate paediatric data justification
Correspondence from Swissmedic regarding SwissMedic-2021-0089. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-589
Type
question
Application
Authority
Swissmedic
Category
Administrative
Risk
Medium
Due Date
2025-01-31
Status
Open
Owner
Priya Sharma
Created
2023-06-26
Correspondence Body
Dear SwissMedic Review Team,
With reference to application SwissMedic-2021-0089, 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
data_table_589.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.