GDUFA Research Outcomes
Complex Routes of Delivery
The Generic Drug User Fee Amendments (GDUFA) science and research program facilitates patient access to high-quality generic drugs by advancing research in areas where generic product development has been limited or prevented due to knowledge gaps about the kind of evidence needed to demonstrate that a generic product is the same as its brand name reference listed drug product. Leaders and experts across the generic industry collaborate to establish GDUFA research priorities for the most pressing scientific challenges they face with generic product development. Scientists and clinicians from industry, academia, and the U.S. Food and Drug Administration (FDA) strategically design research in these areas so that the outcomes help to build scientific bridges across the knowledge gaps, thereby facilitating pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop.
A major GDUFA science and research priority is to enhance the efficiency of bioequivalence (BE) approaches for complex routes of delivery, such as locally-acting gastrointestinal (GI), buccal, sublingual, inhalation, nasal, ophthalmic, otic, and topical dermatological, vaginal and rectal products. The advancement of research in this area focuses on understanding of how ingredients and other aspects of a formulation influence drug absorption via complex routes of delivery, building in vivo predictive models and identifying corresponding failure modes for BE, to support the development of efficient BE approaches for these products.
Outcomes including scientific publications, presentations, and posters arising from GDUFA-funded research in this priority area are available in this section.
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FDA Sponsored Drug Research Towards Generics for Dermatology
Luke, Markham C
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FDA for the Dermatologist – The Basics About FDA and Advances in Science and Regulation of Topical Generic Drugs
Luke, Markham
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On Understanding the Clinical Relevance of “Formulation” for Topical Applied to the Skin
Luke, Markham
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Advancing the Science of How Topically Applied Drugs Penetrate the Skin and Clinical Relevance – The Viewpoint of an FDA Dermatologist
Luke, Markham C
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FDA and Dermatology – Topical Drug Products: New Paradigm for Generics
Luke, Markham
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FDA and the Dermatologist – The Basics about FDA and a New Paradigm for Generic Topical Drug Bioequivalence
Luke, Markham C
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Bioequivalence of Transdermal Systems
Luke, Markham
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Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Luke, Markham; Witzmann, Kimberly; Conti, Denise
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Generic Drugs for Dermatology
Luke, Markham
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Generic Drugs and Their Role in Bringing Next Generation Products: An FDA Perspective
Luke, Markham