Request for post-marketing commitment progress update

Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0073. Type: question. Risk: medium. Category: Labeling.

Correspondence ID
COR-073
Type
question
Application
CDSCO-2022-0073
Authority
Central Drugs Standard Control Organisation
Category
Labeling
Risk
Medium
Due Date
2025-03-05
Status
Completed
Owner
Dmitri Volkov
Created
2022-07-11
Correspondence Body
Dear CDSCO Review Team, With reference to application CDSCO-2022-0073, 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
data_table_73.xlsx
Response Package
Response package assembled: RP-073