Office of Generic Drugs Fiscal Year 2018 GDUFA Science and Research Report

Today, the Food and Drug Administration (FDA) published the Fiscal Year (FY) 2018 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, and this report elaborates on the results of these efforts during FY 2018, which marks the first year of GDUFA II.

During FY 2018, the Office of Generic Drugs (OGD), through its Office of Research and Standards (ORS), awarded 13 new research contracts and 11 grants for innovative research projects on generics. Awards correspond to the FY 2018 science priorities, 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 includes 7 topic areas with an additional 6 topics soon to follow reflecting the total 13 topic areas. It also includes comprehensive lists of grants and contracts that the GDUFA science program and research covered in FY 2018. These activities support our regulatory decision-making through the development of general and Product-Specific Guidances (PSGs). In FY 2018, OGD provided industry with 136 new PSGs as a roadmap for generic drug development. When needed, OGD engages with industry through pre-ANDA meetings related to complex products, and, in FY 2018, the agency received 83 pre-ANDA meeting requests.

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: Office of Generic Drugs FY 2018 GDUFA Science and Research Report