Query: container closure integrity study methodology

Correspondence from National Medical Products Administration regarding NMPA-2021-0084. Type: question. Risk: high. Category: Labeling.

Correspondence ID
COR-484
Type
question
Application
NMPA-2021-0084
Authority
National Medical Products Administration
Category
Labeling
Risk
High
Due Date
2024-12-15
Status
In Progress
Owner
Priya Sharma
Created
2022-08-06
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0084, we wish to address the following: [Detailed response body regarding request for additional clinical data on primary endpoint] 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_484.pdfdata_table_484.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.