FDA publishes FY 2019 GDUFA Science and Research Report

Today, the Food and Drug Administration (FDA) published the Fiscal Year 2019 (FY2019) GDUFA Science and Research Report.

The Generic Drug User Fee Amendments of 2012 (GDUFA) established a formal regulatory science program and funded research activities for investigating new methodologies and tools for development of generic drugs. GDUFA was reauthorized in 2017 through 2022 (GDUFA II), and this report elaborates on the results of these efforts during FY2019, which marks the second year of GDUFA II.

This annual report reflects the GDUFA-funded research activities carried out by FDA and external grantees. Research activities follow the FY2019 GDUFA Regulatory Science Priority Initiatives, which fall broadly into the following categories:

• Complex active ingredients, formulations, or dosage forms
• Complex routes of delivery
• Complex drug-device combination products
• Tools and methodologies for bioequivalence and substitutability evaluation

The report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts that the GDUFA Science and Research program awarded in FY2019. 

Research activities support our regulatory advice and decision-making across the generic drug program. In FY2019, we provided industry with 252 new and revised Product-Specific Guidances (PSGs) as a roadmap for generic drug development. FDA also engages with industry through pre-Abbreviated New Drug Application (ANDA) meetings related to complex products, and in FY2019, the agency received 112 pre-ANDA meeting requests. Complex generic products are typically harder to develop, which means that many complex products face less competition than other products, and therefore can be more expensive and less accessible to the patients who need them.

We want to thank our external and internal collaborators who have contributed greatly to this effort and look forward to the future scientific achievements that will help enhance access to generic drugs for the American public.

The report can be viewed in its entirety at: FY2019 GDUFA Science and Research Report.