Deficiency: inadequate paediatric data justification
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0047. Type: information-request. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-147
Type
information-request
Application
Authority
Therapeutic Goods Administration
Category
Nonclinical
Risk
Medium
Due Date
2025-02-21
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-02-01
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0047, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
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_147.xlsxattachment_147_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.