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)

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby

• Formulation Considerations for In Vitro Characterization Based Approaches of Locally Acting Complex Generic Drug Products

  Kozak, Darby

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

  Kozak, Darby

• Development and Status of Product-Specific Guidances for Topical Products

  Kelchen, Megan

• An Overview of the Current Product-Specific Guidances for Topical Products

  Kelchen, Megan

• Current Trends in Product-Specific Guidance Development & Revisions for Topical Products

  Kelchen, Megan

• General Considerations for the “No Significant Difference” Evaluation of a Proposed Generic Formulation

  Kelchen, Megan

• An FDA Perspective on the Comparative Analyses of Critical Material, Quality, and Design Attributes for Topical, Transdermal, Rectal, and Vaginal Drug-Device Combination Products

  Kelchen, Megan

• “No Difference” Standard vs. Q1/Q2 Sameness for Topical Drug Products

  Kelchen, Megan

• The Development And Application Of Surrogate Methods To Assess Bioequivalence Of Topical Generic Products Intended For Local Action

  Kanfer,Isadore