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FDA Finalizes Guidance on User Fee Changes Under PDUFA VI

Posted 02 May 2018 | By Zachary Brennan 

FDA Finalizes Guidance on User Fee Changes Under PDUFA VI

The US Food and Drug Administration (FDA) on Wednesday finalized guidance without any substantive changes from the draft on the new fee structure under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), and the types of fees for which industry is responsible.

FDA said it reviewed the comments submitted to the docket on the draft from last October “and determined that they did not raise any relevant issues.”

PDUFA VI created a structure whereby human drug application fees will account for 20% and prescription drug program fees will account for 80% of the total revenue amount for that fiscal year.

Previously, FDA collected human drug application and supplement fees, prescription drug establishment fees and prescription drug product fees.

PDUFA VI eliminates fees for supplements as well as for establishments, though applicants will be assessed annual prescription drug program fees for prescription drug products, rather than the prescription drug product fee assessed under the previous iteration of PDUFA.

“In addition, PDUFA VI eliminates a provision under which applicants could apply for a waiver or refund of user fees on the basis that the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of human drug applications for such person, also known as the ‘the fees-exceed-costs waiver,’” the guidance notes.

The guidance also features information on when and where prescription drug products are listed, the “same product as another product” prescription drug program fee exception, liquid parenteral biological products, the orphan drug exemption and waivers on PDUFA fees.

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry
 

Categories: Regulatory News

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