Question on comparative dissolution data
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0023. Type: question. Risk: medium. Category: Labeling.
Correspondence ID
COR-123
Type
question
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Labeling
Risk
Medium
Due Date
2025-02-26
Status
In Progress
Owner
Lieselotte van der Berg
Created
2023-08-14
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0023, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_123.pdfattachment_123_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.