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)

• Questions about the Proposed Topical Classification System (TCS), and What To Do With It.

  Raney, Sam

• FDA Champions Research to Make Complex Generic Transdermal Products Available to Patients

  Raney, Sam

• FDA Regulatory Initiatives Related to Generic Dermatological and Transdermal Drug Products

  Raney, Sam

• Strategies to Improve Patient Access to High Quality Topical Products

  Raney, Sam

• The journey from Developing the Research Studies to Drafting a New Regulatory Standard: A Case Study with Acyclovir Cream

  Raney, Sam

• GDUFA Research and Regulatory Initiatives for Complex Topical Products

  Raney, Sam

• Cutaneous Pharmacokinetics and pharmacodynamics for the 21st Century

  Raney, Sam

• Equivalence of Locally-Acting Drug Products

  Raney, Sam

• In Vitro Characterization of Topical Semisolid Dosage Forms

  Raney, Sam

• Facilitating Patient Access to High Quality Generics: A Case Study in Regulatory Science

  Raney, Sam