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  1. Generic Drugs

Generic Drug Research-Related Guidances & Reports

The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. FDA's Office of Generic Drugs also publishes an annual research report each fiscal year, summarizing the research activities and outcomes from extramural and intramural projects.

Notable Guidances Related to GDUFA Science and Research Projects

FDA publishes product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs Tto facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support Abbreviated New Drug Application (ANDA) approval. Recent product-specific recommendations for complex products developed as a result of regulatory science projects include:

GDUFA Science and Research Reports

These annual reports describe the activities and progress in each of five regulatory science priority areas.

GDUFA Science and Research Outcomes

A compilation of all research outcomes for a given fiscal year.

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