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)

• Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency

  Frost, Mitchell

• Product-Specific Guidance Fundamentals from a Clinical Perspective

  Frost, Mitchell

• Keynote: Non-traditional Approaches to Bioequivalence & Application of Clinical Pharmacology to Minimize Barriers to Generic Drug Substitution

  Uhl, Kathleen

• Overview of Pre-ANDA Meeting Program

  Hakeem, Susan

• Characterization and Comparative Evaluation Strategies to Demonstrate Complex Excipient Sameness

  Qin, Bin

• GDUFA II: Pre-ANDA Program Metrics and Tips for Success

  Prodduturi, Suneela

• How can Scientific Advancements Help Align Global Development of Complex Generic Products

  Jiang, Wenlie

• Scientific Gaps that Impact the Prediction of Fed BE Studies

  Ni, Zhanglin

• Development of Complex Generic Drugs in the United States

  Luke, Markham C

• Careers in Pharmacology Symposium: The FDA

  Luke, Markham C