GDUFA Research Outcomes

Nanotechnology Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to generic products that contain nanomaterials or nanotechnology (e.g., colloidal iron-carbohydrate and liposomal products).

• All(28)
• Posters(6)
• Presentations(16)
• Papers(6)

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

  Kozak, Darby

• Biomaterials as Pertains to Drug Products, including Generic Drug Products with Biomaterial Components

  Luke, Markham

• Approaches Using Proactive Research in Support of Product-Specific Guidance (PSG) Development

  Xu, Xiaoming

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

  Kozak, Darby

• Development and Characterization of Generic Drug Products Containing Nanomaterials

  Kozak, Darby

• Complex Generics Containing Nanomaterials: Developments in 2021 and 2022

  Jiang, Wenlei

• Regulating Generic Nanotechnology Drug Products: Guidance and Standards

  Jiang, Wenlei

• Regulatory Research in Nanomedicine Drug Products

  Jiang, Wenlei

• US FDA Perspectives for Bioequivalence (BE) Evaluation of Liposome Drug Products

  Jiang, Wenlei

• Excipients in Parenteral Drug Products

  Jiang, Wenlei