Request for updated SmPC section 4.1
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0073. Type: commitment-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-173
Type
commitment-request
Application
Authority
Central Drugs Standard Control Organisation
Category
Clinical
Risk
Medium
Due Date
2025-03-07
Status
In Progress
Owner
Priya Sharma
Created
2023-04-20
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0073, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_173.pdfattachment_173_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.