Request for additional clinical data on primary endpoint
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0065. Type: commitment-request. Risk: low. Category: Labeling.
Correspondence ID
COR-065
Type
commitment-request
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Labeling
Risk
Low
Due Date
2024-12-24
Status
Open
Owner
Marcus Webb
Created
2024-03-06
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0065, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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: 2024-12-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.