GDUFA Research Outcomes

Other Generics Resaerch

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

• Closing Remarks – May 1, 2019 Generic Drug Research Public Workshop

  Lionberger, Robert

• FY 2019 GDUFA Regulatory Science Initiatives Public Workshop

  Lionberger, Robert

• Innovative Approaches for Complex Generics

  Lionberger, Robert

• Path to Bioequivalence for Complex Products: Past, Present and Future

  Lionberger, Robert

• 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

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

  Le, Christine

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

  Le, Christine