GDUFA Research Outcomes

Other Generics Resaerch

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

• Bridging the Difference: Case Studies that Demonstrate Bioequivalence Assessments for Approved Suitability Petitions

  Boyce, Heather

• FDA Product-Specific Guidance Program Overview

  Bengston, Karen

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

  Zhao, Liang

• The GDUFA II Pre-ANDA Program for Complex Products

  Andre, Kris

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

  Andre, Kris

• Practical Tips on Using the CDER NextGen Collaboration Portal

  Andre, Kris

• Pre-ANDA Meeting or Controlled Correspondence?

  Andre, Kris

• Complex Products – GDUFA II Pre-ANDA Program

  Andre, Kris