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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Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing
Manna, Soumyarwit
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Bioequivalence Considerations for Conducting Bridging Studies with Orally Inhaled and Nasal Drug Products
Ma, Tian
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Navigating the Transition to Low Global Warming Potential Propellants
Luke, Markham C
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History of Dermatology and Dermatologists at the U.S. Food and Drug Administration
Luke, Markham
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FDA Science and Regulation for the Physician Scientist
Luke, Markham
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FDA�۪s Regulation of Drug Products Used by Dermatologists and Dermatologic Surgeons
Luke, Markham
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FDA Update: FDA and Dermatologic DEIA
Luke, Markham
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FDA Update: FDA and Dermatology DEIA
Luke, Markham
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Innovation and Topical Generic Drug Science: A Case of Targeted and Planned Innovation
Luke, Markham
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Generic Drugs and Dermatology: Bioequivalence and Access Equity
Luke, Markham