Query regarding bioequivalence study design
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0099. Type: question. Risk: high. Category: Nonclinical.
Correspondence ID
COR-299
Type
question
Application
Authority
Ministry of Health of Russia
Category
Nonclinical
Risk
High
Due Date
2025-04-27
Status
Open
Owner
James O'Brien
Created
2024-02-13
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0099, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
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_299.pdf
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.