Question on comparative dissolution data
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0065. Type: commitment-request. Risk: medium. Category: Quality.
Correspondence ID
COR-265
Type
commitment-request
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Quality
Risk
Medium
Due Date
2025-04-04
Status
Overdue
Owner
Tomoko Ikeda
Created
2022-09-13
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0065, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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: 2025-04-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.