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(111)
• Posters(33)
• Presentations(58)
• Papers(20)

• 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

• Bioequivalence Evaluation of Narrow Therapeutic Index Drugs – Rationales for the Current Regulatory Approach by U.S. FDA

  Jiang, Wenlei

• U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products

  Jiang, Wenlei