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)

• Predicting, Measuring, and Optimising Drug Delivery to the Skin

  Guy, Richard

• Analysis of ANDA Approval and Major Deficiencies – A Case Study with Topical Products

  Ghosh, Priyanka

• Role of Regulatory Science Research Topical Product Development

  Ghosh, Priyanka

• Impact of GDUFA Regulatory Science and Research Program on Topical Product Availability

  Ghosh, Priyanka

• Characterization-Based Bioequivalence Approaches for Topical Products Part 1: Q3 Guidance

  Ghosh, Priyanka

• GDUFA Science and Research Collaborating with the FDA Research Program

  Ghosh, Priyanka

• Visualizing and Quantifying Drugs Dermal Drug Development

  Ghosh, Priyanka

• Translating Scientific Advances to Regulatory Methods Assessment of Cutaneous Pharmacokinetics

  Ghosh, Priyanka

• Characterization Based Approaches for Establishing Bioequivalence Locally Acting Drug Products Applied to the Skin

  Ghosh, Priyanka; Luke, Markham

• Product Development Considerations and Bioequivalence Strategies for Generic Topical Products

  Ghosh, Priyanka