GDUFA Research Outcomes

Other Generics Research

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.

• All(113)
• Posters(9)
• Presentations(91)
• Papers(13)

• Generic Drug Science & Research Priorities for Fiscal Year (FY) 2023

  Raney, Sameersingh

• GDUFA II: Pre-ANDA Program and Meetings for Complex Generic Products

  Sarago, Caliope

• Approach to a Comparative Analysis When the RLD is Unavailable

  Soukup, Stephanie

• Regulatory Considerations on Dose-Scale Analysis in Assessing Pharmacodynamic Equivalence

  Gong, Xiajing

• FDA Initiatives to Stimulate Innovation and Improve Patient Access to Generic Topical & Transdermal Products Part II

  Ghosh, Priyanka

• Biopharmaceutics and Bioequivalence a Day in the Life

  Wu, Fang

• Complex Drug Products and Potential Challenges to Generic Drug Development

  Zhang, Lei

• Opening Remarks

  Zhang, Lei

• ICH Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs

  Zhang, Lei

• Role of Regulatory Science in Generic Drug Development and Application Assessment

  Zhang, Lei; Lee, Sau