Information request: manufacturing process change justificat

Correspondence from Food and Drug Administration regarding FDA-2024-0081. Type: question. Risk: medium. Category: Labeling.

Correspondence ID
COR-381
Type
question
Application
FDA-2024-0081
Authority
Food and Drug Administration
Category
Labeling
Risk
Medium
Due Date
2024-12-11
Status
Draft
Owner
Dmitri Volkov
Created
2022-08-28
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0081, 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
data_table_381.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-11 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.