Information request: extractables and leachables data
Correspondence from ANMAT regarding ANMAT-2020-0035. Type: question. Risk: medium. Category: Clinical.
Correspondence ID
COR-035
Type
question
Application
Authority
ANMAT
Category
Clinical
Risk
Medium
Due Date
2024-12-31
Status
Open
Owner
Nadia Petrova
Created
2023-08-27
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0035, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
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: 2024-12-31 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.