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(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• Advancing the Science of How Topically Applied Drugs Penetrate the Skin and Clinical Relevance – The Viewpoint of an FDA Dermatologist

  Luke, Markham C

• FDA and the Dermatologist – The Basics about FDA and a New Paradigm for Generic Topical Drug Bioequivalence

  Luke, Markham C

• Equivalence of Locally-Acting Drug Products

  Luke, Markham

• On Understanding the Clinical Relevance of “Formulation” for Topical Applied to the Skin

  Luke, Markham

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby

• Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods

  Kozak, Darby

• Bioequivalence of Transdermal Systems

  Luke, Markham

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

  Luke, Markham

• Generic Drugs for Dermatology

  Luke, Markham

• Implications of Skin Anatomy, Skin (Patho-)Physiology, and Product Physico-Chemistry on FDA Regulatory Apprach for Generic Dermatologic Products

  Luke, Markham