Question on comparative dissolution data

Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0019. Type: query. Risk: low. Category: Nonclinical.

Correspondence ID
COR-119
Type
query
Application
Roszdravnadzor-2021-0019
Authority
Ministry of Health of Russia
Category
Nonclinical
Risk
Low
Due Date
2025-01-26
Status
In Progress
Owner
Lieselotte van der Berg
Created
2023-08-07
Correspondence Body
Dear Roszdravnadzor Review Team, With reference to application Roszdravnadzor-2021-0019, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.