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(57)
• Posters(10)
• Presentations(44)
• Papers(3)

• FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products

  Zhang, Lei K

• FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products

  Zhang, Lei

• A Deep Dive: GDUFA III Scientific Meetings Introduction

  Zhang, Lei

• Regulatory Science to Support Global Harmonization for Establishing BE for Generic Oral Products

  Zhang, Lei

• ICH M13 Guideline Series

  Zhang, Lei

• Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”

  Zhang, Lei; Tampal, Nilufer; Kim, Myong Jin

• Identify Research Needs and PSG Development for Complex Products

  Xu, Xiaoming

• Regulatory Perspective of Model Master Files Utilities for Oral Drug Products

  Wu, Fang

• Statistical Experience and Challenges In Assessing Similarity Of Dissolution Profiles, Particle Size Distributions and API Sameness

  Tsong, Yi

• Considerations and Potential Regulatory Applications for a Model Master File

  Tsakalozou, Eleftheria