Deficiency: inadequate paediatric data justification
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0039. Type: deficiency. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-339
Type
deficiency
Application
Authority
Ministry of Health of Russia
Category
Nonclinical
Risk
Medium
Due Date
2025-01-20
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-06-11
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0039, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.