Deficiency: inadequate paediatric data justification
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0023. Type: deficiency. Risk: medium. Category: Clinical.
Correspondence ID
COR-023
Type
deficiency
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Clinical
Risk
Medium
Due Date
2024-12-12
Status
Completed
Owner
Marcus Webb
Created
2024-01-25
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0023, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_23_1.pdf
Response Package
Response package assembled: RP-023