FDA issues updated guidance on implementing GDUFA II

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The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).

Guidance V13F21

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 Further updates to user fee structures are clarified in the draft guidance.

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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

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