Request for updated SmPC section 4.1
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0025. Type: query. Risk: low. Category: Nonclinical.
Correspondence ID
COR-025
Type
query
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Nonclinical
Risk
Low
Due Date
2024-12-26
Status
Draft
Owner
James O'Brien
Created
2022-08-10
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0025, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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: 2024-12-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.