Request for additional clinical data on primary endpoint

Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0053. Type: commitment-request. Risk: medium. Category: Clinical.

Correspondence ID
COR-553
Type
commitment-request
Application
CDSCO-2022-0053
Authority
Central Drugs Standard Control Organisation
Category
Clinical
Risk
Medium
Due Date
2025-02-12
Status
Open
Owner
Aisha Okonkwo
Created
2023-04-20
Correspondence Body
Dear CDSCO Review Team, With reference to application CDSCO-2022-0053, we wish to address the following: [Detailed response body regarding request for benefit-risk assessment addendum] 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: 2025-02-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.