FY 2023 generic research priority initiatives at FDA

The US Food and Drug Administration (FDA) yesterday released its fiscal year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives, including feedback on the scientific priorities during the  FY 2022 Generic Drug Science and Research Initiatives Public Workshop, that was held on May 9-10, 2022.

The FY 2023 priority initiatives encompass scientific challenges that the generic industry and FDA’s generic drug program identify as being significant over the next five years (in reauthorized GDUFA III), and they also represent opportunities for scientific advances to accelerate access to generic versions of complex products and make the development of generic drugs more efficient and globally harmonized.

Scientific advancements in these areas would maximize the use of the generic drug process to supply needed medications, modernizing the generic drug program to use advances in data science and models in application assessments.