FDA Finalizes Guidance on PDUFA Fee Waivers

The FDA outlined when sponsors can seek waivers, reductions or refunds of Prescription Drug User Fee Act (PDUFA) fees, in a final guidance.

The agency will look at three factors when considering whether a drug application qualifies for a fee waiver or reduction — if the waiver is necessary to protect the public health, if the fee would present a significant barrier to innovation due to limited resources, and if the applicant is a small business.

PDUFA fees do not apply to orphan designated products, to applications submitted by government entities for drugs not being commercially distributed, or to withdraw applications with “no substantial work” performed, the guidance notes. 

Applications for fee waivers should be submitted about three to four months before submission of a product application. To qualify for a waiver, reduction or refund for a fee paid, an applicant must submit a written request no later than 180 calendar days after the fee is due.