GDUFA Research Outcomes

Injectable Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to injectable generic drug products.

• All(140)
• Posters(51)
• Presentations(34)
• Papers(55)

• Development and Characterization of Generic Drug Products Containing Nanomaterials

  Kozak, Darby

• Considerations for Post-Approval Changes to Complex Generic Drug Products

  Kozak, Darby

• A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges

  Kozak, Darby

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

• Complex Generics Containing Nanomaterials: What’s Next in the Pipeline?

  Jiang, Wenlei

• Complex Generics Containing Nanomaterials: Developments in 2021 and 2022

  Jiang, Wenlei

• Advances in Iron Colloid Products: Product-Specific Guidance Discussion

  Jiang, Wenlei

• Complex Drug Products Containing Nanomaterials

  Jiang, Wenlei

• Liposome Guidance

  Jiang, Wenlei