Information request: extractables and leachables data
Correspondence from Food and Drug Administration regarding FDA-2024-0061. Type: commitment-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-061
Type
commitment-request
Application
Authority
Food and Drug Administration
Category
Clinical
Risk
Medium
Due Date
2025-03-06
Status
Completed
Owner
Aisha Okonkwo
Created
2024-02-11
Correspondence Body
Dear FDA Review Team,
With reference to application FDA-2024-0061, 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-061