Regulatory Opportunities to Advance Generic Drug Repurposing

Addressing the barriers to generic drug repurposing is not a one-dimensional challenge and will require efforts across the biomedical system of researchers, developers, funders, regulators, and payers. In this paper, we explore the role that drug regulators, specifically at the U.S. Food and Drug Administration (FDA), could play in unlocking the full potential of generic drugs to improve patient access to affordable treatments.