Information request: manufacturing process change justificat
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0005. Type: query. Risk: high. Category: Administrative.
Correspondence ID
COR-005
Type
query
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Administrative
Risk
High
Due Date
2025-03-31
Status
Draft
Owner
Aisha Okonkwo
Created
2024-01-01
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0005, 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
study_report_5.pdfdata_table_5.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.