Question on comparative dissolution data
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0045. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-545
Type
question
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Nonclinical
Risk
Medium
Due Date
2025-02-11
Status
Overdue
Owner
Lieselotte van der Berg
Created
2022-09-15
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0045, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_545.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.