Deficiency letter: missing stability data for 40°C condition
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0079. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-479
Type
question
Application
Authority
Ministry of Health of Russia
Category
Labeling
Risk
Medium
Due Date
2024-12-05
Status
Draft
Owner
Priya Sharma
Created
2022-07-19
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 benefit-risk assessment addendum]
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_479.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.