FDA publishes FY2018 GDUFA Science and Research Outcomes

FDA publishes FY2018 GDUFA Science and Research Outcomes 

Today, the Food and Drug Administration published a new web page, Fiscal Year (FY) 2018 GDUFA Science and Research Outcomes, to provide greater transparency regarding the important work the Agency engages in to advance the science of generic drugs and provide generic drug developers, applicants, and FDA reviewers essential tools and information to help expedite the availability of high-quality, lower-cost, safe, and effective generic drugs.

This web page includes a list of research outcomes from the previous fiscal year in one easily accessible place. These outcomes are also included in the FY 2018 GDUFA Science and Research Report, which has recently been updated to include all topic areas.

The new web page will provide information on the following types of research outcomes:

• GDUFA research supporting the development of generic drug products
• GDUFA research supporting the generation of evidence needed to support efficient review and timely approval of ANDAs
• GDUFA research supporting the evaluation of generic drug equivalence

The results of research studies conducted under GDUFA support the development of general and product-specific guidances and provide new tools for FDA to evaluate generic drug equivalence, which can result in the development and approval of safe and effective generic drug products for the American public. The web page also fulfills of the Agency‘s Generic Drug User Fee Amendments of 2017 (GDUFA II) commitment to provide this important information to the public.

The GDUFA Science and Research Outcomes for Fiscal Year 2018 can be viewed in its entirety at: https://www.fda.gov/drugs/generic-drugs/fy-2018-gdufa-science-and-research-outcomes