Request for post-marketing commitment progress update
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0045. Type: query. Risk: medium. Category: Quality.
Correspondence ID
COR-145
Type
query
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Quality
Risk
Medium
Due Date
2024-12-15
Status
Draft
Owner
Carlos Mendez
Created
2023-07-27
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0045, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
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: 2024-12-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.