Information request: extractables and leachables data
Correspondence from Agência Nacional de Vigilância Sanitária regarding ANVISA-2020-0085. Type: question. Risk: high. Category: Quality.
Correspondence ID
COR-085
Type
question
Application
Authority
Agência Nacional de Vigilância Sanitária
Category
Quality
Risk
High
Due Date
2025-04-13
Status
Completed
Owner
Tomoko Ikeda
Created
2023-11-21
Correspondence Body
Dear ANVISA Review Team,
With reference to application ANVISA-2020-0085, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Package
Response package assembled: RP-085