Question on comparative dissolution data

Correspondence from National Medical Products Administration regarding NMPA-2021-0024. Type: question. Risk: medium. Category: Nonclinical.

Correspondence ID
COR-424
Type
question
Application
NMPA-2021-0024
Authority
National Medical Products Administration
Category
Nonclinical
Risk
Medium
Due Date
2025-01-06
Status
In Progress
Owner
Carlos Mendez
Created
2023-02-11
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0024, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] 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: 2025-01-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.