Request for updated SmPC section 4.1
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0093. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-593
Type
query
Application
Authority
Central Drugs Standard Control Organisation
Category
Administrative
Risk
Medium
Due Date
2025-02-07
Status
Draft
Owner
Marcus Webb
Created
2022-11-23
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0093, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_593_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.