GDUFA Research Outcomes

Transdermal Products

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

• All(114)
• Posters(34)
• Presentations(59)
• Papers(21)

• Generic Drugs and Their Role in Bringing Next Generation Products: An FDA Perspective

  Luke, Markham

• Combination Drug-Device Products as Complex Generic Drugs- Summary of Presentations and Horizon Scanning for Future Scientific Research

  Luke, Markham

• Bioequivalence of Tansdermal Delivery Systems-Scientific Merits of the U.S. Approach

  Luke, Markham

• Drug Compounding and the Dermatologist

  Luke, Markham

• Closing Remarks

  Lionberger, Robert

• Topical Bioequivalence Update

  Lionberger, Robert

• Topical Bioequivalence Update

  Lionberger, Robert

• Advantages and Challenges in Implementing New Analytical Methods that Arise from Regulatry Science Initiatives

  Kozak, Darby

• Advantages and Challenges in Implementing New Analytical Methods that Arise from Regulatry Science Initiatives

  Kozak, Darby

• An FDA Perspective on the Comparative Analyses of Critical Material, Quality, and Design Attributes for Topical, Transdermal, Rectal, and Vaginal Drug-Device Combination Products

  Kelchen, Megan