Question on comparative dissolution data
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0013. Type: deficiency. Risk: high. Category: Labeling.
Correspondence ID
COR-413
Type
deficiency
Application
Authority
Central Drugs Standard Control Organisation
Category
Labeling
Risk
High
Due Date
2025-04-11
Status
Overdue
Owner
Sarah Chen
Created
2024-01-31
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0013, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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_413.xlsxattachment_413_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.