Deficiency: inadequate paediatric data justification
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0005. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-105
Type
query
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Administrative
Risk
Medium
Due Date
2025-04-26
Status
In Progress
Owner
Carlos Mendez
Created
2022-07-28
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0005, 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
study_report_105.pdfdata_table_105.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.