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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• Overview of Breakout Session on Topical Drug Products: Workshop on Complex Generic Drug Products (CGDPs)

  Raney, Sam

• When Do Formulation Differences in Topical Dosage Forms Impact Their Function: Emerging Insights and Implications for Bioequivalence Approaches

  Raney, Sam

• Advances in Topical Bioequivalence Assessments: Characterization-Based Approaches

  Raney, Sam

• A Generic Drugs Perspective on the Use of In Vitro Assesment Methods

  Raney, Sam

• Research Activities, Scientific Advances, & Modernization of Bioequivalence Standards for Generic Topical and Transdermal Products

  Raney, Sam

• A Generic Perspective On The Use Of In Vitro Assessment Methods

  Raney, Sam

• FDA Initiatives to Stimulate Innovation and Imporve Patient Access to Generic Topical & Transdermal Products Part l

  Raney, Sam

• Overview of Current Science Based Regulatory Standards

  Raney, Sam

• Questions about the Proposed Topical Classification System (TCS), and What To Do With It.

  Raney, Sam

• FDA Regulatory Initiatives Related to Generic Dermatological and Transdermal Drug Products

  Raney, Sam