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)

• GDUFA III Teleconferences and Meetings

  Zhang, Lei

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

  Boyce, Heather

• Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development

  Zhang, Lei

• Scientific Harmonization of Bioequivalence Standards for Generic Drugs

  Zhang, Lei

• Harmonization of Bioequivalence FDA Perspective

  Zhang, Lei

• Drug-Drug Interactions and Generic Drugs

  Zhang, Lei

• Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development

  Zhang, Lei

• Role of Regulatory Science in Reducing Barries to Generic Drug Product Development

  Zhang, Lei

• ICH Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs

  Zhang, Lei

• U.S. FDA Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs -Update-

  Zhang, Lei