- October 19 - 20, 2020
- - ET
- - ET
The Generic Drug User Fee Amendments of 2012 (GDUFA I) established a regulatory science and research program that was subsequently reauthorized under the FDA Reauthorization Act of 2017 (GDUFA II). Research initiatives from these programs have identified many challenges related to complex drug-device combination products that will benefit from expanded collaboration with stakeholders.
The workshop will examine current knowledge and ongoing scientific research by FDA supporting evidence-based development, assessment, and approval of complex generic drug-device combination products. Speakers will discuss these topics, as well as common review issues and challenges, expectations for industry after product approval, and future directions for the development of generics of these important therapeutic products.
A program committee including members from the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation Office of Generic Drugs, Office of Pharmaceutical Quality, and other relevant offices across FDA, the DIA’s planning committee members drawn from the Drug and Device Community of Interest, and other DIA members and industry stakeholders designed this conference.
This meeting is an open forum for the current discussion of topics of mutual scientific and practical interest to audience members such as researchers, product development scientists, and policy analysts who develop and/or have an interest in the development of generic drug-device combination products. A primary goal for this meeting is to establish an ongoing dialogue between industry, academia, and regulators to better address the scientific and regulatory challenges associated with the development of a therapeutically equivalent generic drug-device combination product.
- Discuss relevant regulatory and policy considerations for drug-device combination products
- Identify scientific considerations for establishing bioequivalence for different complex drug-device combination product delivery methods
- Identify specific product quality challenges in developing different approaches to drug-device combination product manufacturing to meet product performance and cGMP requirements
- Discuss ideas for improving communication and collaboration between industry, academia and the agency in developing novel methods and standards for assessing the sameness of complex generic drug-device combination products.
The workshop will appeal to researchers and product development scientists who are involved in the development of generic drug-device combination products. Interested persons may also include biopharmaceutical consultants, clinicians, regulatory and medical scientists, and other stakeholders interested in the regulatory and scientific landscape associated with generic drug-device combination products.