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ORIGINAL ARTICLE
Year : 2022  |  Volume : 14  |  Issue : 1  |  Page : 7-15

Impact of generic drug user fee act and other initiatives on generic drug approval process in the USA


1 Centre for Drug Regulatory Affairs and Pharmacy Practice, Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, Uttar Pradesh; Mankind Research Centre, Gurgaon, Haryana, India
2 Centre for Drug Regulatory Affairs and Pharmacy Practice, Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, Uttar Pradesh, India
3 Mankind Research Centre, Gurgaon, Haryana, India
4 Gokaraju Rangaraju College of Pharmacy, Hyderabad, Telangana, India

Correspondence Address:
Arti R Thakkar
Amity Institute of Pharmacy, Amity University Uttar Pradesh, Sector 125, Noida - 201 303, Uttar Pradesh
India
Giriraj T Kulkarni
Gokaraju Rangaraju College of Pharmacy, Hyderabad - 500 090, Telangana,
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ajprhc.ajprhc_7_21

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Introduction: Regulations of the drug approval process either new drug or generic has come a long way. Hatch-Waxman Act was one of the most important milestones in the drug regulations history of the USA, followed by various acts such as the Prescription Drug User Fee Act and Generic Drug User Fee Act (GDUFA). Methods: In this study, various data related to generic drug submission and approval were evaluated and critically reviewed, specifically impact of GDUFA II. Results and Discussion: Although the first 5-year term of GDUFA, i.e., GDUFA I was majorly known for clearing backlog at the Food and Drug Administration (FDA), enhancing resources, and putting processes in place, it is the second 5-year term, GDUFA II, which is expected to bring the real benefit to industry in the form of higher-number and faster approvals, including increased first-cycle approvals. Apart from reduction in abbreviated new drug application approval times, more focus has also come on approval of first generic, complex products, increased FDA-Industry meetings to resolve complex matters, and reforms on review of DMFs. Conclusion: GDUFA legislation is credited for giving push to the availability of generic drugs by increased competition and it now helps save more than USD 300 Bn annually for the American healthcare system.


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