Question on comparative dissolution data

Correspondence from Food and Drug Administration regarding FDA-2024-0001. Type: deficiency. Risk: medium. Category: Clinical.

Correspondence ID
COR-301
Type
deficiency
Application
FDA-2024-0001
Authority
Food and Drug Administration
Category
Clinical
Risk
Medium
Due Date
2025-02-13
Status
Draft
Owner
James O'Brien
Created
2023-04-13
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0001, 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
study_report_301.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.