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.

• All(1036)
• Posters(360)
• Presentations(435)
• Papers(241)

• Advances in Topical Bioequivalence Assessments: Characterization-Based Approaches

  Raney, Sam

• A Generic Drugs Perspective on the Use of In Vitro Assesment Methods

  Raney, Sam

• Research Activities, Scientific Advances, & Modernization of Bioequivalence Standards for Generic Topical and Transdermal Products

  Raney, Sam

• A Generic Perspective On The Use Of In Vitro Assessment Methods

  Raney, Sam

• FDA Initiatives to Stimulate Innovation and Imporve Patient Access to Generic Topical & Transdermal Products Part l

  Raney, Sam

• Facilitating Patient Access to High-Quality Generic Transdermal Products: The Role of FDA and GDUFA

  Raney, Sam

• Overview of Current Science Based Regulatory Standards

  Raney, Sam

• Questions about the Proposed Topical Classification System (TCS), and What To Do With It.

  Raney, Sam

• FDA Champions Research to Make Complex Generic Transdermal Products Available to Patients

  Raney, Sam

• FDA Regulatory Initiatives Related to Generic Dermatological and Transdermal Drug Products

  Raney, Sam