Information request: manufacturing process change justificat
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0013. Type: query. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-213
Type
query
Application
Authority
Central Drugs Standard Control Organisation
Category
Nonclinical
Risk
Medium
Due Date
2025-02-11
Status
Draft
Owner
James O'Brien
Created
2023-10-13
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0013, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.