Query: container closure integrity study methodology
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0013. Type: question. Risk: low. Category: Clinical.
Correspondence ID
COR-013
Type
question
Application
Authority
Central Drugs Standard Control Organisation
Category
Clinical
Risk
Low
Due Date
2025-02-08
Status
In Progress
Owner
Tomoko Ikeda
Created
2023-10-30
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0013, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_13.pdfattachment_13_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.