Request for post-marketing commitment progress update
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0093. Type: question. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-093
Type
question
Application
Authority
Central Drugs Standard Control Organisation
Category
Nonclinical
Risk
Medium
Due Date
2025-03-06
Status
Open
Owner
Aisha Okonkwo
Created
2022-06-18
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0093, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.