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)

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

  Kelchen, Megan

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

  Kelchen, Megan

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

  Kelchen, Megan

• General Considerations for the ���No Significant Difference�۝ Evaluation of a Proposed Generic Formulation

  Kelchen, Megan

• ���No Difference�۝ Standard vs. Q1/Q2 Sameness for Topical Drug Products

  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

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

  Kanfer,Isadore

• Bioequivalence Evaluation of Narrow Therapeutic Index Drugs – Rationales for the Current Regulatory Approach by U.S. FDA

  Jiang, Wenlei

• U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products

  Jiang, Wenlei

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei