GDUFA Research Outcomes

Topical Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.

• All(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• Beyond the API: Role of Formulation in Topical Product Development

  Ghosh, Priyanka

• Advancing In Silico Methods and Future Opportunities for Understanding Impact of Compositional Differences on Performance

  Walenga, Ross

• FDA’s Role in Regulating Products for Dermatology, Including Drugs, Biologics, Devices, and Cosmetics – With a Special Focus on Generic Drugs

  Luke, Markham

• FDA’s Role in Regulating Products for Dermatology, Including Drugs, Biologics, Devices, and Cosmetics – With a Special Focus on Generic Drugs

  Luke, Markham

• Development of FDA’s Guidance for Industry on IVPT Studies for Topical Drug Products Submitted in ANDAs

  Raney, Sam G.

• In Vitro Permeation Testing (IVPT)

  Luke, Markham

• Navigating Formulation Assessment: Considerations for Products that are Not Required to be Q1Q2

  Jiang, Ying

• Current Status and Outstanding Challenges IVPT Studies

  Ghosh, Priyanka

• Impact of Cream Composition on Critical Quality Attributes of Miconazole Nitrate Vaginal Creams

  Xu, Zizhao; Zhou, Chenfei; Desai, Krisha Hardik; Kelchen, Megan; Xie, Lingxiao; Ghosh, Priyanka; Shen, Jie

• Sensory Panel Tests for Topical Semi-Solid Creams: Correlation Between Sensorial Perceptions and Product Critical Quality Attributes

  Phan, Khanh; Leite-Silva, Vania R; Prakash, Sangeeta; Liu, David; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam G; Luke, Markham; Roberts, Michael; Mohammed, Yousuf