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# GDUFA Regulatory Science Priorities
- URL: https://www.fdaweb.com/gdufa-regulatory-science-priorities/
- Published: 2016-10-27T12:00:00.000Z
- Updated: 2026-09-14T21:43:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137197

Under terms of the Generic Drug User Fee Amendments of 2012, FDA is to prepare a yearly list of regulatory science priorities for generic drugs based on input from industry and other stakeholders. The agency has released this [list](http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM526900.pdf?ref=fdaweb.com) of priorities for FY 2017: 

- post-market evaluation of generic drugs, including research into monitoring methods, understanding patient perceptions of generic drug quality and effectiveness, and verifying therapeutic effectiveness through brand-to-generic switching studies;
- equivalence of complex drug products, including research into making generic versions available in all product categories, including complex drugs with unique characteristics;
- equivalence of locally-acting products, including research into new bioequivalence methods and pathways for locally-acting drugs;
- therapeutic equivalence evaluation and standards to support the evolution of risk-based equivalence and product quality standards to ensure therapeutic equivalence across all dosage forms and delivery routes; and
- computational and analytical tools including physiologically-based pharmacokinetic or absorption models, pharmacodynamic or clinical trial simulation, systems biology, and quantitative risk modeling.