GMP inspection findings clarification
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0033. Type: question. Risk: high. Category: Labeling.
Correspondence ID
COR-333
Type
question
Application
Authority
Central Drugs Standard Control Organisation
Category
Labeling
Risk
High
Due Date
2025-02-16
Status
Draft
Owner
James O'Brien
Created
2023-06-02
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 benefit-risk assessment addendum]
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_333.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.