Deficiency: inadequate paediatric data justification
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0045. Type: question. Risk: high. Category: Quality.
Correspondence ID
COR-445
Type
question
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Quality
Risk
High
Due Date
2025-01-09
Status
Open
Owner
Marcus Webb
Created
2024-01-05
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0045, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data 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_445.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.