Query regarding bioequivalence study design
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0025. Type: commitment-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-425
Type
commitment-request
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Clinical
Risk
Medium
Due Date
2025-04-04
Status
In Progress
Owner
James O'Brien
Created
2023-06-04
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0025, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_425.pdfattachment_425_1.pdf
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.