Deficiency: inadequate paediatric data justification
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0005. Type: query. Risk: low. Category: Clinical.
Correspondence ID
COR-205
Type
query
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Clinical
Risk
Low
Due Date
2025-03-22
Status
Overdue
Owner
Aisha Okonkwo
Created
2022-05-02
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0005, 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_205.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.