The Generic Drug User Fee Amendments (GDUFA) science and research program facilitates patient access to high-quality generic drugs by advancing research in areas where generic product development has been limited or prevented due to knowledge gaps about the kind of evidence needed to demonstrate that a generic product is the same as its brand name reference listed drug product. Leaders and experts across the generic industry collaborate to establish GDUFA research priorities for the most pressing scientific challenges they face with generic product development. Scientists and clinicians from industry, academia, and the U.S. Food and Drug Administration (FDA) strategically design research in these areas so that the outcomes help to build scientific bridges across the knowledge gaps, thereby facilitating pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop.
Outcomes including scientific publications, presentations, and posters arising from GDUFA-funded research across the major GDUFA science and research priority areas are available in this section.
The listed research outcomes represent those up to April 2023. More research outcomes will be added to the site in batches on an ongoing basis. Please subscribe to our newsletter and follow us on LinkedIn and Twitter to receive an update when new information is added. We are working to continuously improve this resource for the generic industry, and we welcome feedback on any improvements or corrections to this resource at info@complexgenerics.org
