Query regarding bioequivalence study design

Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0079. Type: commitment-request. Risk: high. Category: Nonclinical.

Correspondence ID
COR-379
Type
commitment-request
Application
Roszdravnadzor-2021-0079
Authority
Ministry of Health of Russia
Category
Nonclinical
Risk
High
Due Date
2025-03-01
Status
Open
Owner
Tomoko Ikeda
Created
2022-11-24
Correspondence Body
Dear Roszdravnadzor Review Team, With reference to application Roszdravnadzor-2021-0079, we wish to address the following: [Detailed response body regarding deficiency: inadequate paediatric data justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
data_table_379.xlsxattachment_379_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.