Information request: extractables and leachables data

Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0079. Type: information-request. Risk: medium. Category: Clinical.

Correspondence ID
COR-079
Type
information-request
Application
Roszdravnadzor-2021-0079
Authority
Ministry of Health of Russia
Category
Clinical
Risk
Medium
Due Date
2025-01-05
Status
Overdue
Owner
Priya Sharma
Created
2023-06-06
Correspondence Body
Dear Roszdravnadzor Review Team, With reference to application Roszdravnadzor-2021-0079, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] 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_79.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.