In 2020 we submitted a small business waiver request 4 months before an anticipated NDA submission. The waiver was not granted until 5 1/2 months later. Fortunately, the funds were available to pay the fee and a refund was automatically issued once the waiver was granted.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 28-Jul-2023 09:19
From: Bridgette Kunst
Subject: PDUFA fee waiver request - recent experience on review time
Has anyone had recent experience with PDFUFA fee waiver request (small business or other) and status of Agency review time? Recognizing the guidance suggests submission of the waiver request 3-4 months in advance of marketing application, I am looking to find out if the Agency is keeping in this timing. This is important for a small business that can't pay the fee upfront and get a refund.
Thank you in advance for sharing any recent experiences!
Bridgette
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Bridgette Kunst MA, RAC
Managing Director
Bridge Regulatory Affairs, LLC
bkunst@bridgereg.com
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