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’s Role in Drug Delivery Technology Innovation

  Lionberger, Robert

• An Overview of the FDA Product-Specific Guidance (PSG) Program Under GDUFA III

  Le, Christine

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

  Kotsybar, Joseph

• Deep Dive into Generic Drug Applications to Seek Data-Driven Harmonization of Bioequivalence Criteria for Narrow Therapeutic Index Drugs

  Jiang, Wenlei

• Data-driven & Science-based Recommendation on Harmonization of Bioequivalence Standards for Narrow Therapeutic Index Drugs

  Jiang, Wenlei

• Advancing Toward Harmonized Global Scientific and Technical Standards for Generic Drugs

  Ibrahim, Sarah; Tampal, Nilufer; Zhang, Lei

• Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs: First-Year Review

  Gong, Yuqing

• Ask us about the GDUFA III Research Program

  Floura, Jessie

• Generic Drug-Device Combination Product Research – focus on comparative device user interface assessment and understanding how differences impact users

  Feibus, Katharine

• Considerations for Application Pathway: 505(b)(2) or ANDA

  Coppersmith, Dave