FDA and industry agree on terms of GDUFA II reauthorization

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According to minutes from the US Food and Drug Administration (FDA)–Industry Generic Drug User Fee Amendments (GDUFA) Reauthorization Meeting, held on 24 August 2016, FDA and industry have agreed on the terms of a GDUFA II reauthorization package and negotiations have concluded.

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Industry groups, including the Generic Pharmaceutical Association (GPhA) and the Pharma & Biopharma Outsourcing Association (PBOA) participated in GDUFA II reauthorization negotiation sessions. Both these groups have applauded the successful conclusion of the negotiations, which will extend the GDUFA for a further five-year period, covering FY2018 to FY2022.

GDUFA provides extra funds for FDA via the collection of fees from generics makers and active pharmaceutical ingredient manufacturers. These extra funds have enabled the agency to hire more staff and therefore carry out more reviews for new generics applications. This resulted in the agency approving the highest number of generics ever in 2015 [1].

The commitments outlined in GDUFA II should enable FDA to continue ensuring access to safe and effective generics. The funds will be applied toward streamlining and expediting the application review and approval process, improving regulatory consistency and predictability, and ensuring timely access to generics.

GDUFA II includes key improvements, metrics and resource provisions intended to streamline the review process for abbreviated new drug applications (ANDAs), enhancing FDA’s inspection infrastructure, and increase accountability, while providing relief for small businesses.

Key provisions of GDUFA II include:
• GDUFA backlog ANDA provisions
• Priority and standard review
• Enhanced communication and transparency
• Complex product meetings
• Enhancements to the Inactive Ingredient Database (IID)
• Resource management and planning, and performance reporting
• Small business relief

GPhA believes that the provisions of this agreement will streamline approvals by assigning goal dates to all ANDAs and assuring that no submissions from GDUFA I are left behind.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA approves highest number of generics in 2015 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Generics/General/FDA-approves-highest-number-of-generics-in-2015

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Source: GPhA, PBOA, US FDA

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