Question on comparative dissolution data
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0063. Type: question. Risk: high. Category: Nonclinical.
Correspondence ID
COR-463
Type
question
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Nonclinical
Risk
High
Due Date
2024-12-07
Status
In Progress
Owner
Carlos Mendez
Created
2023-01-02
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0063, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.