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Session 4 Part B: Scientific Research, Development, and Regulatory Considerations for Complex Generic Transdermal Products
Session Chair(s)
Sam G. Raney, PhD, MS
Associate Director for Science, ORS, Office of Generic Drugs, CDER, FDA, United States
Transdermal Delivery Systems (TDS), also known as patches, are complex drug-device combination products that are used to treat a wide variety of disease indications affecting millions of patients in the United States. Patient access to these products can be greatly enhanced by the availability of affordable generic TDS, however, the development of generic TDS can be challenging for a variety of reasons. The inherent complexity of the product design and quality attributes means that there are a myriad of interrelated product performance considerations that must be successfully addressed in order to develop a generic TDS product.
This session will include an introductory presentation that discusses some of the unique and complex issues related to TDS products, as well as presentations from speakers offering academic, industry, and regulatory perspectives on the scientific research, product development, and regulatory perspectives. The session will conclude with a 30-minute panel discussion, intended to engage all the participants in the audience and on the panel.
Learning Objective : - Understand the challenges in developing complex generic drug-device implantable products such as intrauterine systems
- Discuss how Transdermal Delivery Systems might be evaluated for equivalence with regard to product design and quality attributes such as product adhesion
- Better understand the future landscape of drug-device combination products and possible scientific needs to advance the pertinent equivalence issues
Speaker(s)
Charles DiLiberti, MS
President, Montclair Bioequivalence Services, LLC, United States
Product Development Challenges for Generic Transdermal Products: An Industry Perspective
Sam G. Raney, PhD, MS
Associate Director for Science, ORS, Office of Generic Drugs, CDER, FDA, United States
Facilitating Patient Access to High-Quality Generic Transdermal Products: The Role of FDA and GDUFA
Audra L. Stinchcomb, PhD
Professor, University of Maryland, United States
Scientific Challenges for Generic Transdermal Products: Recent Advances and Future Research
Markham Luke, MD, PhD
Director for Therapeutic Performance, Office of Generic Drugs, CDER, FDA, United States
Combination Drug-Device Products as Complex Generic Drugs – Summary of Presentations and Horizon Scanning for Future Scientific Research
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