Information request: extractables and leachables data
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0033. Type: deficiency. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-233
Type
deficiency
Application
Authority
Central Drugs Standard Control Organisation
Category
Nonclinical
Risk
Medium
Due Date
2024-12-17
Status
Open
Owner
Priya Sharma
Created
2022-07-20
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0033, we wish to address the following:
[Detailed response body regarding query regarding bioequivalence study design]
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_233.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.