GDUFA Research Outcomes

Other Generics Resaerch

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

• Generic Ophthalmic Drug Products, Physical Characteristics, and Bioequivalence

  Kozak, Darby

• Non-Complex Drug Products and Product-Specific Guidances

  Kim, Myong Jin

• How can Scientific Advancements Help Align Global Development of Complex Generic Products

  Jiang, Wenlie

• Navigating Q1/Q2 for Complex Generics

  Jiang, Xiaohui

• Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• “Genericize” the Complex Drug Product Landscape

  Jiang, Wenlei

• Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• Overview of Pre-ANDA Meeting Program

  Hakeem, Susan

• Regulatory Considerations on Dose-Scale Analysis in Assessing Pharmacodynamic Equivalence

  Gong, Xiajing

• FDA Initiatives to Stimulate Innovation and Improve Patient Access to Generic Topical & Transdermal Products Part II

  Ghosh, Priyanka