GMP inspection findings clarification
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0053. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-053
Type
question
Application
Authority
Central Drugs Standard Control Organisation
Category
Administrative
Risk
Medium
Due Date
2025-03-08
Status
Open
Owner
Tomoko Ikeda
Created
2023-04-08
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0053, 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
data_table_53.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.