GDUFA Research Outcomes

Other Generics Resaerch

• All(111)
• Posters(8)
• Presentations(90)
• Papers(13)

• Approach to a Comparative Analysis When the RLD is Unavailable

  Soukup, Stephanie

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

  Sarago, Caliope

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

  Raney, Sam

• Characterization and Comparative Evaluation Strategies to Demonstrate Complex Excipient Sameness

  Qin, Bin

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

  Prodduturi, Suneela

• Scientific Gaps that Impact the Prediction of Fed BE Studies

  Ni, Zhanglin

• Development of Complex Generic Drugs in the United States

  Luke, Markham C

• Product-Specific Guidances for Complex Generic Drugs

  Luke, Markham

• Complex Product Workshop

  Luke, Markham

• Incentivizing Generic Drug Competition

  Luke, Markham