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)

• Non-Complex Drug Products and Product-Specific Guidances

  Kim, Myong Jin

• Complex Product Workshop

  Luke, Markham

• Evaluating Therapeutic Performance of Complex Generic Drugs for Pulmonary Delivery: The FDA Generic Drug Approval Process

  Luke, Markham

• Incentivizing Generic Drug Competition

  Luke, Markham

• What’s Important to Consider When Developing a Complex Drug

  Lionberger,Robert

• Bioequivalence and Complex Generics: How to Get Pre-submission Advice

  Lionberger,Robert

• GDUFA II Pre-ANDA Program Meetings for Complex Products

  Lionberger,Robert

• Using Quantitative Methods and Modeling to Transform Generic Drug Development and Review

  Lionberger,Robert

• Complex Generics 2022 Update

  Lionberger, Robert

• Overview of the FDA Product-Specific Guidance (PSG) Program

  Le, Christine