Query regarding bioequivalence study design
Correspondence from European Medicines Agency regarding EMA-2023-0002. Type: deficiency. Risk: high. Category: Nonclinical.
Correspondence ID
COR-402
Type
deficiency
Application
Authority
European Medicines Agency
Category
Nonclinical
Risk
High
Due Date
2024-12-28
Status
Overdue
Owner
Dmitri Volkov
Created
2023-04-29
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0002, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_402_1.pdfdata_table_402.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-28 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.