Information request: manufacturing process change justificat
Correspondence from ANMAT regarding ANMAT-2020-0055. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-455
Type
query
Application
Authority
ANMAT
Category
Administrative
Risk
Medium
Due Date
2024-12-21
Status
Overdue
Owner
Dmitri Volkov
Created
2023-10-01
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0055, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
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_455.pdfdata_table_455.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.