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)

• Role of GDUFA Research on Resolving Technical and Regulatory Challenges for Complex Generic Drug Development and Approval

  Wang, Yan

• From Bench to Approval: the Role of GDUFA Research in Promoting Complex Generics

  Wang, Yan

• Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients

  Wang, Yan

• Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations

  Wang, Yan

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

• Considerations and Expectations for in Vitro Release Testing of Complex Formulations

  Wang, Yan

• Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations

  Wang, Yan

• Characterization of Complex Excipients and Formulations

  Wang, Yan

• Long Acting Injectable and Implantable Drug Product Development Regulatory Challenges and Considerations_GSK-CRS Conference

  Wang, Yan

• Challenges Associated with Development of Generic PLGAPLA Based Drug Products

  Wang, Yan