Deficiency letter: missing stability data for 40°C condition
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0063. Type: information-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-063
Type
information-request
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Clinical
Risk
Medium
Due Date
2025-04-14
Status
Draft
Owner
Sarah Chen
Created
2024-03-05
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0063, 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
data_table_63.xlsx
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.