Information request: extractables and leachables data
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0059. Type: question. Risk: low. Category: Quality.
Correspondence ID
COR-459
Type
question
Application
Authority
Ministry of Health of Russia
Category
Quality
Risk
Low
Due Date
2025-02-25
Status
Overdue
Owner
Sarah Chen
Created
2022-09-28
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0059, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
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_459.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.