Information request: extractables and leachables data

Correspondence from National Medical Products Administration regarding NMPA-2021-0024. Type: deficiency. Risk: high. Category: Labeling.

Correspondence ID
COR-324
Type
deficiency
Application
NMPA-2021-0024
Authority
National Medical Products Administration
Category
Labeling
Risk
High
Due Date
2025-01-06
Status
Draft
Owner
Dmitri Volkov
Created
2023-03-10
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0024, 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_324.pdfdata_table_324.xlsx
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.