Deficiency: inadequate paediatric data justification
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0059. Type: question. Risk: medium. Category: Clinical.
Correspondence ID
COR-259
Type
question
Application
Authority
Ministry of Health of Russia
Category
Clinical
Risk
Medium
Due Date
2025-04-20
Status
Overdue
Owner
Nadia Petrova
Created
2023-03-09
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0059, 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
study_report_259.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.