Deficiency letter: missing stability data for 40°C condition
Correspondence from National Medical Products Administration regarding NMPA-2021-0004. Type: information-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-104
Type
information-request
Application
Authority
National Medical Products Administration
Category
Clinical
Risk
Medium
Due Date
2025-02-24
Status
Draft
Owner
Priya Sharma
Created
2023-01-07
Correspondence Body
Dear NMPA Review Team,
With reference to application NMPA-2021-0004, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_104.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-24 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.