Query regarding bioequivalence study design
Correspondence from ANMAT regarding ANMAT-2020-0055. Type: question. Risk: low. Category: Quality.
Correspondence ID
COR-255
Type
question
Application
Authority
ANMAT
Category
Quality
Risk
Low
Due Date
2025-04-27
Status
Overdue
Owner
James O'Brien
Created
2022-11-19
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0055, 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_255_1.pdfdata_table_255.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.