Question on comparative dissolution data
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0099. Type: deficiency. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-099
Type
deficiency
Application
Authority
Ministry of Health of Russia
Category
Nonclinical
Risk
Medium
Due Date
2025-05-01
Status
In Progress
Owner
Sarah Chen
Created
2024-02-13
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0099, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_99_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-05-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.