Query: container closure integrity study methodology

Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0005. Type: commitment-request. Risk: high. Category: Administrative.

Correspondence ID
COR-505
Type
commitment-request
Application
ANVISA-2020-0005
Authority
Agência Nacional de Vigilância Sanitária
Category
Administrative
Risk
High
Due Date
2025-02-16
Status
Open
Owner
Priya Sharma
Created
2023-10-01
Correspondence Body
Dear ANVISA Review Team, With reference to application ANVISA-2020-0005, 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: 2025-02-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.