Query regarding bioequivalence study design
Correspondence from Therapeutic Goods Administration regarding TGA-2023-0007. Type: deficiency. Risk: low. Category: Nonclinical.
Correspondence ID
COR-007
Type
deficiency
Application
Authority
Therapeutic Goods Administration
Category
Nonclinical
Risk
Low
Due Date
2025-04-15
Status
Completed
Owner
Marcus Webb
Created
2023-01-04
Correspondence Body
Dear TGA Review Team,
With reference to application TGA-2023-0007, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Package
Response package assembled: RP-007