USFDA Guidance: Assessing User Fees Under the PDUFA of 2022

This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, jointly released final guidance on "Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022".

PDUFA stands for Prescription Drug User Fee Act, which is a law passed by the US Congress in 1992 that aims to provide the FDA with a stable and consistent source of funding to maintain a predictable and efficient review process, improve patient safety, and enhance product quality.

This guidance explains how the USFDA will implement the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) under Title I of The FDA User Fee Reauthorization Act of 2022.

This guidance document clarifies the changes that have been introduced by PDUFA VII in the user fee program. These changes pertain to various aspects such as revised definitions, alterations in PDUFA fee exceptions, waivers, exemptions, reductions, and returns.

The guidance explains the varieties of user fees approved under PDUFA VII and elucidates how the FDA decides which products are liable to pay such fees, the payment submission process to the FDA, the repercussions of not paying PDUFA fees, and details the procedure for requesting a reassessment of user fees.

There are three exceptions to the PDUFA application fee

1. Previously Filed Applications

   1. was submitted by a person that paid the fee for the application;

   2. was accepted for filing; and

   3. was not approved or was withdrawn prior to approval (without a waiver);

2. Designated Orphan Drug

3. Skin-Test Diagnostic Products

Click this LINK to know more about the Waivers of PDUFA fees & payment procedures.