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)

• Topical Semisolid Drug Product Critical Quality Attributes (Q3 Characterization) with Relevance to Topical Bioequivalence

  Murthy, Narasimha

• Characterizing Failure Modes And Critical Quality (Q3) Attributes Of Semi-Solid Topical Drug Products

  Murthy, Narasimha

• Evaluating Quality (Q3) Attributes And Potential Failure Modes For Topical Semisolid Drug Products

  Murthy, Narasimha

• Equivalence of Locally-Acting Drug Products

  Luke, Markham

• FDA’s Regulation of Drug Products Used by Dermatologists and Dermatologic Surgeons

  Luke, Markham

• History of Dermatology and Dermatologists at the U.S. Food and Drug Administration

  Luke, Markham

• FDA Science and Regulation for the Physician Scientist

  Luke, Markham

• FDA Update: FDA and Dermatologic DEIA

  Luke, Markham

• Innovation and Topical Generic Drug Science: A Case of Targeted and Planned Innovation

  Luke, Markham

• Generic Drugs and Dermatology: Bioequivalence and Access Equity

  Luke, Markham