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FDA’s Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles

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Abstract

Implementation of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act of 2012 (Generic Drug User Fee Amendments. https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments) successfully allowed the U.S. Food and Drug Administration (FDA) to modernize review of Abbreviated New Drug Applications (ANDAs) with goal dates. The goal of this study was to assess the success of GDUFA I in decreasing ANDA time to approval and the number of review cycles across the five fiscal years of GDUFA I. Results of this study underscore FDA’s continuous progress within its generic drug program and highlight the ongoing collaborative communication process between FDA and ANDA applicants that must continue for the timely approval of high-quality, safe, and effective generic drugs for the American public.

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Notes

  1. 2018 Generic Drug Access and Savings in the U.S.: Access in Jeopardy. Association for Accessible Medicines, February 2019. https://www.accessiblemeds.org/resources/blog/2018-generic-drug-access-and-savings-report.

  2. Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics. Therapeutic Innov Regul Sci, October 25, 2018. https://www.journals.sagepub.com/https://doi.org/10.1177/2168479018806192.

  3. Information Requests and Discipline Review Letters Under GDUFA: Guidance for Industry. December 2017. https://www.fda.gov/media/109915/download.

  4. Activities Report of the Generic Drug Program (FY 2017) https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/activities-report-generic-drug-program-fy-2017.

  5. Activities Report of the Generic Drugs Program (FY 2018) – GDUFA II Quarterly Performance. https://www.fda.gov/drugs/generic-drugs/activities-report-generic-drugs-program-fy-2018-gdufa-ii-quarterly-performance

  6. See footnote 3

Acknowledgements

The authors would like to acknowledge Susan Laine, Zili Li, MD, and Rong (Gloria) Fu, PhD, for their assistance in developing this article.

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Authors and Affiliations

  1. U.S. Food and Drug Administration, Office of Generic Drugs, Silver Spring, MD, USA

    Howard Chazin MD, MBA & Jason Woo MD, MPH

  2. U.S. Food and Drug Administration, Office of Translational Sciences, Silver Spring, MD, USA

    Jing Han PhD, Stella Grosser PhD & Jingyu Luan PhD

  3. U.S. Food and Drug Administration, Office of Generic Drugs, 10903 New Hampshire Avenue, 75-3662, Silver Spring, MD, 20993, USA

    Howard Chazin MD, MBA

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  1. Howard Chazin MD, MBA
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  2. Jason Woo MD, MPH
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  3. Jing Han PhD
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  4. Stella Grosser PhD
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  5. Jingyu Luan PhD
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Correspondence to Howard Chazin MD, MBA.

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Chazin, H., Woo, J., Han, J. et al. FDA’s Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles. Ther Innov Regul Sci 54, 758–763 (2020). https://doi.org/10.1007/s43441-019-00016-2

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  • DOI: https://doi.org/10.1007/s43441-019-00016-2

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