Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
ICR Documents
Supporting Statement A
Document
Date Uploaded
0338 BLAs Supporting Statement 2023 REV.docx
02/26/2023
Supporting Statement B
Document
Date Uploaded
Supplementary Documents
Title
Document
Document Type
Date Uploaded
Request for Changes to PDUFA Forms
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx
Justification for No Material/Nonsubstantive Change
09/01/2022
Public Comments
Author Name
Comment Document
Author Affiliation
Sponsoring Org.
Type
Category
Date of Comment
Date Comment Received
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
An official website of the United States government
The .gov means it's official.
The site is secure.
