Request for updated SmPC section 4.1
Correspondence from Food and Drug Administration regarding FDA-2024-0021. Type: question. Risk: medium. Category: Clinical.
Correspondence ID
COR-021
Type
question
Application
Authority
Food and Drug Administration
Category
Clinical
Risk
Medium
Due Date
2024-12-25
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-05-25
Correspondence Body
Dear FDA Review Team,
With reference to application FDA-2024-0021, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_21_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-25 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.