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.
-
Advances in Topical Bioequivalence Assessments: Characterization-Based Approaches
Raney, Sam
-
A Generic Drugs Perspective on the Use of In Vitro Assesment Methods
Raney, Sam
-
Research Activities, Scientific Advances, & Modernization of Bioequivalence Standards for Generic Topical and Transdermal Products
Raney, Sam
-
A Generic Perspective On The Use Of In Vitro Assessment Methods
Raney, Sam
-
FDA Initiatives to Stimulate Innovation and Imporve Patient Access to Generic Topical & Transdermal Products Part l
Raney, Sam
-
Overview of Current Science Based Regulatory Standards
Raney, Sam
-
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