Information related to FDA’s preparation for the fourth reauthorization of GDUFA will be hosted on this page as it becomes available.
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Novel Drug Approvals for 2026
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Generic Drug Facilities, Sites and Organization Lists
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This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.
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Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
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Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
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Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.
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HYRNUO is a tyrosine-kinase inhibitor that is indicated for the treatment of adult patients with non-squamous non-small cell lung cancer. Learn more about the drug trials.
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This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs).
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint
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An informative webinar on the FDA guidance Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
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