Home / Guidelines / FDA issues updated guidance on implementing GDUFA II

FDA issues updated guidance on implementing GDUFA II Posted 13/12/2019

The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).

GDUFA is a law enacted by Congress in 2012 intended to accelerate access to safe and effective generic drugs. Fees required under GDUFA are used to help FDA perform its regulatory functions and enhance the timelines of generic drug application reviews. GDUFA applies to all firms that manufacture generic drugs that are distributed in the US. In 2017, GDUFA was reauthorized up until September 2022 under GDUFA II [1].

Under GDUFA II, FDA is authorized to collect five types of fees: backlog fees, drug master file fees, abbreviated new drug application filing fees, active pharmaceutical ingredient (API) and finished dosage form (FDF) facility fees, and GDUFA programme fees. The guidance provides detail on these user fees and describes the process for submitting payments to FDA, the consequences for failing to pay user fees and the process for requesting a reconsideration of a user fee assessment. It also explains how FDA determines affiliation for purposes of assessing user fees.

Using public comments submitted on the 2017 guidance, the revised guidance is intended to clarify and explain changes from GDUFA I to assist industry in complying with GDUFA II. Changes from GDUFA I include the elimination of prior approval supplement fees and the addition of GDUFA programme fees for the number of approved generic drug applications that the company and its affiliates own. In addition, facilities that manufacture APIs and FDFs previously incurred both API and FDF fees, but under GDUFA II only incur FDF fees.

Moreover, facilities that are only referenced in pending submissions will not need to pay a facility fee under GDUFA II, and contract manufacturing organizations that make FDFs only need to pay one-third of the FDF facility fee. Further updates to user fee structures are clarified in the draft guidance.

Related articles
FDA issues post-CRL meeting guidance for generics makers

FDA issues final guidance on ANDA/PAS amendments

FDA to speed up review of priority generics

FDA and industry agree on terms of GDUFA II reauthorization

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Generic Drug User Fee Act is a benefit to the Indian pharmaceutical industry, study finds [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 13]. Available from: www.gabionline.net/Generics/Research/Generic-Drug-User-Fee-Act-is-a-benefit-to-the-Indian-pharmaceutical-industry-study-finds

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Comments (0)

Generics News Research General

more

Biosimilars News Research General

more