Request for additional clinical data on primary endpoint
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0025. Type: query. Risk: high. Category: Clinical.
Correspondence ID
COR-225
Type
query
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Clinical
Risk
High
Due Date
2025-02-07
Status
Draft
Owner
Dmitri Volkov
Created
2023-06-15
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 post-marketing commitment progress update]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_225.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.