Query: container closure integrity study methodology
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0043. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-543
Type
question
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Nonclinical
Risk
Medium
Due Date
2025-04-08
Status
Overdue
Owner
Marcus Webb
Created
2023-12-31
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0043, we wish to address the following:
[Detailed response body regarding question on comparative dissolution 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_543.xlsxstudy_report_543.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.