Request for benefit-risk assessment addendum
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0008. Type: query. Risk: medium. Category: Clinical.
Correspondence ID
COR-408
Type
query
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Clinical
Risk
Medium
Due Date
2025-03-03
Status
Overdue
Owner
Tomoko Ikeda
Created
2023-06-02
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0008, 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
study_report_408.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-03 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.