Query regarding bioequivalence study design
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0045. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-045
Type
query
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Administrative
Risk
Medium
Due Date
2025-01-06
Status
Open
Owner
Marcus Webb
Created
2022-08-31
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0045, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
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_45.xlsxstudy_report_45.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.