Question on comparative dissolution data

Correspondence from Food and Drug Administration regarding FDA-2024-0041. Type: commitment-request. Risk: medium. Category: Nonclinical.

Correspondence ID
COR-141
Type
commitment-request
Application
FDA-2024-0041
Authority
Food and Drug Administration
Category
Nonclinical
Risk
Medium
Due Date
2025-01-11
Status
Open
Owner
James O'Brien
Created
2023-07-19
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0041, 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 Assembly
Draft Response Actions:
Response deadline: 2025-01-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.