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  1. Generic Drugs

Office of Generic Drugs FY 2018 GDUFA Science and Research Report

Research Topics:

Director’s Message

The Generic Drug User Fee Amendment 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 fiscal year 2018, which marks the first year of GDUFA II. During 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 were made in the FY2018 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

In addition to the extramural program, ORS is heavily engaged in research with other offices and laboratories within FDA, including CDER’s Office of Testing and Research in the Office of Pharmaceutical Quality, the Division of Applied Regulatory Science in the Office of Clinical Pharmacology/Office of Translational Sciences, the Center for Devices and Radiological Health and the National Center for Toxicological Research. These research collaborations have resulted in significant accomplishments in developing the scientific basis supporting new and revised guidances for industry and in refining methods for the scientific evaluation of equivalence for generic drug products.

Innovative approaches for evaluating equivalence and tools that support generic drug development are vital to making quality generic drugs available for complex drug products. Bioequivalence for such products frequently cannot be assessed by traditional pharmacokinetic methods and standards. Complex dosage forms are becoming more critical to patient care but are generally more difficult to develop as generic versions due to lack of adequate equivalence standards and tools. The U.S. Food and Drug Administration regulatory guidance recommendations reflect current scientific knowledge on how to ensure development and manufacture of high quality generic drug products and gain approval based on reproducible, sensitive, scientific standards.

The GDUFA science program and research activities support our regulatory decision-making through the development of general and product-specific guidances (PSGs). In FY2018, OGD provided industry with 136 new PSGs as a roadmap for generic drug development. Where needed, OGD engages with industry through pre-ANDA meetings related to complex products (there were 83 pre-ANDA meeting requests in FY2018).

The OGD research activities are divided into 13 topic areas. A comprehensive list of grants and contracts for all 13 areas can be found below.

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.