Deficiency letter: missing stability data for 40°C condition
Correspondence from ANMAT regarding ANMAT-2020-0095. Type: query. Risk: high. Category: Administrative.
Correspondence ID
COR-095
Type
query
Application
Authority
ANMAT
Category
Administrative
Risk
High
Due Date
2025-04-23
Status
Completed
Owner
Dmitri Volkov
Created
2023-01-14
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0095, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_95_1.pdf
Response Package
Response package assembled: RP-095