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)

• 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 Champions Research to Make Complex Generic Transdermal Products Available to Patients

  Raney, Sam

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

  Raney, Sam

• Strategies to Improve Patient Access to High Quality Topical Products

  Raney, Sam

• The journey from Developing the Research Studies to Drafting a New Regulatory Standard: A Case Study with Acyclovir Cream

  Raney, Sam