Question on comparative dissolution data
Correspondence from European Medicines Agency regarding EMA-2023-0062. Type: question. Risk: medium. Category: Quality.
Correspondence ID
COR-362
Type
question
Application
Authority
European Medicines Agency
Category
Quality
Risk
Medium
Due Date
2025-04-14
Status
Open
Owner
Dmitri Volkov
Created
2024-01-28
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0062, 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
data_table_362.xlsxstudy_report_362.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-14 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.