Request for benefit-risk assessment addendum
Correspondence from European Medicines Agency regarding EMA-2023-0022. Type: question. Risk: medium. Category: Clinical.
Correspondence ID
COR-522
Type
question
Application
Authority
European Medicines Agency
Category
Clinical
Risk
Medium
Due Date
2025-02-21
Status
In Progress
Owner
Priya Sharma
Created
2023-08-02
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0022, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_522.pdfattachment_522_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.