Information request: extractables and leachables data
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0085. Type: deficiency. Risk: low. Category: Administrative.
Correspondence ID
COR-485
Type
deficiency
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Administrative
Risk
Low
Due Date
2025-04-20
Status
Open
Owner
Tomoko Ikeda
Created
2023-10-28
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0085, 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_485.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.