Query regarding bioequivalence study design
Correspondence from European Medicines Agency regarding EMA-2023-0082. Type: query. Risk: medium. Category: Clinical.
Correspondence ID
COR-582
Type
query
Application
Authority
European Medicines Agency
Category
Clinical
Risk
Medium
Due Date
2025-02-23
Status
Open
Owner
Aisha Okonkwo
Created
2022-06-29
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0082, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_582_1.pdfdata_table_582.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.