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)

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

  Luke, Markham

• 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 Dermatology – Topical Drug Products: New Paradigm for Generics

  Luke, Markham

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

  Luke, Markham C

• Bioequivalence of Transdermal Systems

  Luke, Markham

• Generic Drugs for Dermatology

  Luke, Markham

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

  Luke, Markham

• Drug Compounding and the Dermatologist

  Luke, Markham

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

  Luke, Markham

• Overcoming Barriers and Improving Patient Access to Topical Dermatological Drugs

  Luke, Markham