GDUFA Research Outcomes

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Oral and Parenteral Products

The Generic Drug User Fee Amendments (GDUFA) science and research program facilitates patient access to high-quality generic drugs by advancing research in areas where generic product development has been limited or prevented due to knowledge gaps about the kind of evidence needed to demonstrate that a generic product is the same as its brand name reference listed drug product. Leaders and experts across the generic industry collaborate to establish GDUFA research priorities for the most pressing scientific challenges they face with generic product development. Scientists and clinicians from industry, academia, and the U.S. Food and Drug Administration (FDA) strategically design research in these areas so that the outcomes help to build scientific bridges across the knowledge gaps, thereby facilitating pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop.

A major GDUFA science and research priority is to enhance the efficiency of bioequivalence (BE) approaches for oral and parenteral generic products. The advancement of research in this area focuses on understanding of how ingredients in oral and parenteral drug products may modulate bioavailability, and on improving biorelevant dissolution methods as well as in silico models to support the expansion of biowaivers and to support global harmonization under ICH M13A[1]. This includes developing evidence to support the feasibility of biowaivers for immediate release (IR) oral drug products with differences in formulations larger than currently recommended in FDA guidance, or for IR oral drug products that do not demonstrate comparable dissolution profiles across strengths. It also includes establishing approaches to manage potential risks related to subject safety more consistently when developing clinical BE study recommendations and elucidating potential failure modes for BE with special populations (e.g., pediatric or geriatric patients) to improve tools and methodologies that can be incorporated into BE study recommendations which ensure the equivalence of therapeutic outcomes in diverse populations.

Outcomes including scientific publications, presentations, and posters arising from GDUFA-funded research in this priority area are available in this section.

[1] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

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