Query: container closure integrity study methodology

Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0079. Type: query. Risk: low. Category: Administrative.

Correspondence ID
COR-579
Type
query
Application
Roszdravnadzor-2021-0079
Authority
Ministry of Health of Russia
Category
Administrative
Risk
Low
Due Date
2025-03-05
Status
In Progress
Owner
James O'Brien
Created
2023-12-05
Correspondence Body
Dear Roszdravnadzor Review Team, With reference to application Roszdravnadzor-2021-0079, 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
attachment_579_1.pdfstudy_report_579.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.