Question on comparative dissolution data
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0045. Type: commitment-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-345
Type
commitment-request
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Labeling
Risk
Medium
Due Date
2024-12-11
Status
Open
Owner
Dmitri Volkov
Created
2023-03-30
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
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.