Query regarding bioequivalence study design

Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0033. Type: query. Risk: low. Category: Quality.

Correspondence ID
COR-033
Type
query
Application
CDSCO-2022-0033
Authority
Central Drugs Standard Control Organisation
Category
Quality
Risk
Low
Due Date
2025-03-10
Status
Draft
Owner
Marcus Webb
Created
2023-11-08
Correspondence Body
Dear CDSCO Review Team, With reference to application CDSCO-2022-0033, 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_33.pdfdata_table_33.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.