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Agenda
Reg Review
ICR
ICR Documents
Supporting Statement A
Document
Date Uploaded
0014 INDs SSA AUG 2023 to add ICH Guidance REV.docx
08/08/2023
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
83-C to add Special Protocol Assessments (SPAs)
83-C for 0014 to add SPAs MARCH 2023.docx
Justification for No Material/Nonsubstantive Change
03/13/2023
Public Comments
Author Name
Comment Document
Author Affiliation
Sponsoring Org.
Type
Category
Date of Comment
Date Comment Received
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An official website of the United States government
The .gov means it's official.
The site is secure.
