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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• FDA Update: FDA and Dermatology DEIA

  Luke, Markham

• FDA Sponsored Drug Research Towards Generics for Dermatology

  Luke, Markham C

• FDA for the Dermatologist – The Basics About FDA and Advances in Science and Regulation of Topical Generic Drugs

  Luke, Markham

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

  Luke, Markham C

• FDA and Dermatology – Topical Drug Products: New Paradigm for Generics

  Luke, Markham

• 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