Question on comparative dissolution data

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

Correspondence ID
COR-133
Type
query
Application
CDSCO-2022-0033
Authority
Central Drugs Standard Control Organisation
Category
Quality
Risk
Medium
Due Date
2024-12-30
Status
Draft
Owner
Sarah Chen
Created
2023-10-30
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
data_table_133.xlsxstudy_report_133.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.