Request for post-marketing commitment progress update
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0027. Type: question. Risk: low. Category: Clinical.
Correspondence ID
COR-327
Type
question
Application
Authority
Therapeutic Goods Administration
Category
Clinical
Risk
Low
Due Date
2025-01-01
Status
Open
Owner
Aisha Okonkwo
Created
2022-05-26
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0027, 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: 2025-01-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.